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
- PolySenseFDA page
Itamar Medical , Ltd. · Neurology
- eplex RP3 Control M530; eplex RP3 NegativeFDA page
Maine Molecular Quality Controls, Inc. · Microbiology
- Arctic Sun Neonatal ArcticGel PadFDA page
Medivance, Inc. · Cardiovascular
- B`orze Inc Laser Family (Sorren/Adonis)FDA page
Borze, Inc. · General, Plastic Surgery
- Zirconia Collective 4Y Dental Zirconia BlankFDA page
Zirconia Collective, Inc. · Dental
- DS Core DetectFDA page
Dentsply Sirona, Inc. · Radiology
- Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring SystemFDA page
Changsha Sinocare, Inc. · Clinical Chemistry
- VIVO (9002)FDA page
Catheter Precision, Inc. · Cardiovascular
- EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)FDA page
Ever Fortune.Ai, Co., Ltd. · Radiology
- ULSPIRA TS Nitric Oxide Therapy SystemFDA page
Airgas Therapeutics, LLC · Anesthesiology
- Shining3D Clear Aligner SystemFDA page
Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental
- Xpert® Hemorrhagic Fever PanelFDA page
Cepheid · Immunology
- cobas eplex respiratory pathogen panel 3FDA page
GenMark Diagnostics, Inc. · Microbiology
- AngioVac F1885FDA page
AngioDynamics, Inc. · Cardiovascular
- Kerecis Express (50250)FDA page
Kerecis Limited · Unknown
- AutoGel Pad (400-046,400-005)FDA page
Top-Rank Health Care Co., Ltd. · Radiology
- Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)FDA page
Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine
- EXG PulseLinQ Cables (EXGPL)FDA page
Cb Innovations, LLC · Cardiovascular
- Strauss Surgical Cystoscope/Hysteroscope and Accessories InstrumentsFDA page
Strauss Surgical USA · Gastroenterology, Urology
- RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)FDA page
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
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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.