510(k) clearances
Premarket notifications FDA has decided: the device, the applicant, the decision and the product code. 176,299 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- Electric Scooter (FDB08, FDB08A, FDB12)FDA page
Anhui JBH Medical Apparatus Co., Ltd. · Physical Medicine
- Dynamis Pro FamilyFDA page
Fotona D.O.O. · General, Plastic Surgery
- SmartIPL_NI SystemFDA page
Lumenis Be, Ltd. · General, Plastic Surgery
- Pathfinder Endoscope OvertubeFDA page
Neptune Medical, Inc. · Gastroenterology, Urology
- Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)FDA page
Shenzhen Mericonn Technology Co., Ltd. · Anesthesiology
- NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)FDA page
ICU Medical · General Hospital
- Elucid PlaqueIQFDA page
Elucid Bioimaging, Inc. · Radiology
- 25G Huber NeedleFDA page
Martech Medical Products · General Hospital
- EnHAnce PEEK Bunion SystemFDA page
Nvision Biomedical Technologies · Orthopedic
- Dental Diode Laser Device (Laser-Pen)FDA page
Guilin Kevin Peter Technology Co., Ltd. · General, Plastic Surgery
- Deterioration Index Version 2FDA page
Epic Systems Corporation · Cardiovascular
- CrossFAST Integrated Microcatheter Advanced Delivery SystemFDA page
Vantis Vascular, Inc. · Cardiovascular
- MINT MONO SuturesFDA page
Hans Biomed Corporation · General, Plastic Surgery
- Biolinq Shine Autonomous Time-in-Range MicrosensorFDA page
Biolinq Incorporated · Clinical Chemistry
- Triever Duo CatheterFDA page
Inari Medical, Inc. · Cardiovascular
- UNIDRIVE Select SystemFDA page
Karl Storz SE & CO. KG · Obstetrics/Gynecology
- Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)FDA page
ONE BEAUTY Technology Co., Ltd. · General, Plastic Surgery
- Hyperdrive 35 GuidewireFDA page
Rapid-Medical , Ltd. · Cardiovascular
- SLIT LAMP SL-D4 (Type: LED)FDA page
Topcon Corporation · Ophthalmic
- Drainage CatheterFDA page
Canyon Medical, Inc. · Gastroenterology, Urology
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.