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
- CINA-Aneurysm+FDA page
Avicenna.Ai · Radiology
- 7D Surgical System (10-0001)FDA page
7D Surgical ULC · Neurology
- multiFiltratePRO SystemFDA page
Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology, Urology
- Sway System (Sports Plus)FDA page
Sway Medical, Inc. · Neurology
- Sensinel Cardiopulmonary Management (CPM) SystemFDA page
Analog Devices · Cardiovascular
- AVIEW Aorta MetricsFDA page
Coreline Soft Co., Ltd. · Radiology
- Endox Test StripsFDA page
Ibt Scientific · General Hospital
- Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)FDA page
Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology
- Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18FDA page
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology
- Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)FDA page
Sofradim Production · General, Plastic Surgery
- cCeLL - In vivoFDA page
VPIX Medical, Inc. · Neurology
- BCS Bioceramic SealerFDA page
BCS Device Pte., Ltd. · Dental
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)FDA page
Skycade Med Corporation · Cardiovascular
- Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensFDA page
Bausch + Lomb, Inc. · Ophthalmic
- Carecube Negative Pressure Isolation Chamber (1BY)FDA page
Carecubes, Inc. · General Hospital
- BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)FDA page
Becton, Dickinson and Company · Clinical Chemistry
- RestrataFDA page
Acera Surgical, Inc. · Unknown
- MODO DUO Electric Pump (B11621, B11673)FDA page
Tomy International, Inc. · Obstetrics/Gynecology
- Amber ArteFDA page
Hass Corp. · Dental
- Lilium one (USM330)FDA page
Lilium Otsuka Co., Ltd. · Radiology
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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.