510(k) clearances
Premarket notifications FDA has decided: the device, the applicant, the decision and the product code. 176,625 records; openFDA updated it 2026-11-09. About this dataset
Newest records
- SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative ControlFDA page
Maine Molecular Quality Controls, Inc. · Microbiology
- Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody SystemFDA page
Alphatec Spine, Inc. · Orthopedic
- INNI-CERA (BCM-W500, BCM-W1000)FDA page
DentMedi Co., Ltd. · Dental
- Mint ACE PumpFDA page
Beta Bionics, Inc. · Clinical Chemistry
- Access BNP IIFDA page
Beckman Coulter, Inc. · Clinical Chemistry
- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)FDA page
Bd Biosciences · Hematology
- CINA-AneurysmFDA page
Avicenna.Ai · Radiology
- Daybreak Impression MaterialFDA page
Sleepcare, LLC · Dental
- Accuro XVFDA page
Rivanna Medical, Inc. · Radiology
- Picosecond Laser treatment system (Z180)FDA page
Sanhe PERFECTLASER Technology Co., Ltd. · General, Plastic Surgery
- Elecsys HBsAg II quant II RxDxFDA page
Roche Diagnostics · Unknown
- Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)FDA page
Vein 360 · Gastroenterology, Urology
- SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)FDA page
Stryker Instruments · General, Plastic Surgery
- Rongjian Self-adhesive ElectrodeFDA page
Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology
- PDR Airway DeviceFDA page
Park Dental Research Corp. · Dental
- AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)FDA page
Shenzhen Accompany Technology Co., Ltd. · General, Plastic Surgery
- Reprocessed BRK Transseptal NeedleFDA page
Innovative Health, LLC · Cardiovascular
- Freedom Nail Ankle Fusion SystemFDA page
McGinley Orthopaedic Innovations · Orthopedic
- Access MeMed BVFDA page
Beckman Coulter, Inc. · Microbiology
- VenusCTFDA page
Linatech, LLC · Radiology
Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
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.