FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | Jun 13, 2026 |
| P250031 | VENTANA PTEN (SP218) RxDx Assay | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Jun 12, 2026 |
| P250021 | saypha® ChiQ | Croma-Pharma GmbH | Jun 12, 2026 |
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | Jun 12, 2026 |
| K261366 | Virtus | Somnomed, Inc. | Jun 12, 2026 |
| K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | Jun 12, 2026 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | Jun 12, 2026 |
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | Jun 12, 2026 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | Jun 12, 2026 |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | Jun 12, 2026 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | Jun 12, 2026 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | Jun 12, 2026 |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | Jun 12, 2026 |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | Jun 12, 2026 |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | Jun 12, 2026 |
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | Jun 12, 2026 |
| K253437 | Spiro-VISTA | Spiro Robotics | Jun 12, 2026 |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | Jun 12, 2026 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | Jun 12, 2026 |
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | Jun 12, 2026 |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | Jun 12, 2026 |
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | Jun 12, 2026 |
| K252963 | BTL-899TT | BTL Industries, Inc. | Jun 12, 2026 |
| K252937 | ThinkQA 3 | Dosisoft SA | Jun 12, 2026 |
| K252933 | DYNE PORT | Dyne Medical Group, Inc. | Jun 12, 2026 |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | Jun 12, 2026 |
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | Jun 12, 2026 |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | Jun 12, 2026 |
| K261610 | Verge™ Microcatheter | Instylla, Inc. | Jun 11, 2026 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | Jun 11, 2026 |
