510(k) clearances
Premarket notifications FDA has decided: the device, the applicant, the decision and the product code. 176,140 records; openFDA updated it 2026-09-23. About this dataset
Newest records
- Safety lancet (XL)FDA page
Tianjin Huahong Technology Co., Ltd. · General, Plastic Surgery
- Digistat CareFDA page
Ascom Ums Srl Unipersonale · Cardiovascular
- CADDIEFDA page
Odin Medical Limited · Gastroenterology, Urology
- Potenza PrimeFDA page
Jeisys Medical Incorporated · General, Plastic Surgery
- CraniUS PlateFDA page
CraniUS, LLC · Neurology
- Single Use Ureteral Access SheathFDA page
Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology, Urology
- GSPE SpacerFDA page
The General Hospital Corporation, d/b/a Massachusetts · Orthopedic
- Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemFDA page
INNO Holdings Inc. DBA Innovasis · Orthopedic
- CuratOR EX2742FDA page
Eizo Corporation · Gastroenterology, Urology
- SpaceOAR Flex SystemFDA page
Boston Scientific Corporation · Radiology
- iLet Dosing Decision SoftwareFDA page
Beta Bionics, Inc. · Clinical Chemistry
- MICSI-PETFDA page
Microstructure Imaging, Inc. · Radiology
- DRIM-Nail SystemFDA page
41Medical AG · Unknown
- Extroducer Infusion Catheter SystemFDA page
SmartWise Sweden AB · Cardiovascular
- ANTERIONFDA page
Heidelberg Engineering GmbH · Ophthalmic
- Mint ACE PumpFDA page
Beta Bionics, Inc. · Clinical Chemistry
- Ecomed Disposable Administration SetsFDA page
Ecomed Solutions, LLC · General Hospital
- RENASYS DYNAFLOW Kit (66807741)FDA page
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
- PureLift Pro MaxFDA page
Xtreem Pulse, LLC · Neurology
- 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)FDA page
Shenzhen Xinyan Medical Technology Co.,ltd. · Cardiovascular
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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.