FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,724 results

69097–69120 of 174,724

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Dec 30, 2003

CLEARTOOTH DIGITAL X-RAY SYSTEM

Cleartooth Electronics, Inc.

Radiology · 91d

Cleared Dec 30, 2003

EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR

Edwards Lifesciences, LLC

General Hospital · 84d

Cleared Dec 30, 2003

ATHENA PELVIC MUSCLE TRAINER II

Athena Feminine Technologies, Inc.

Gastroenterology & Urology · 82d

Cleared Dec 30, 2003

SMARTSTITCH M-CONNECTOR, MODEL OM-8700

Opus Medical, Inc.

Gastroenterology & Urology · 76d

Cleared Dec 30, 2003

ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY

Varian Medical Systems, Inc.

Radiology · 74d

Cleared Dec 30, 2003

Aalba Dent, Inc.

Cleared Dec 30, 2003

MEDICLUNG, RELEASE 1

Radiology · 64d

Cleared Dec 30, 2003

Heraeus Kulzer, Inc.

Cleared Dec 30, 2003

TRACER METRO SMART WIRE GUIDE

Wilson-Cook Medical, Inc.

Gastroenterology & Urology · 29d

Cleared Dec 30, 2003

MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT

C.R. Bard, Inc.

Gastroenterology & Urology · 26d

Cleared Dec 30, 2003

BEBIG ISOSEED I-125

Bebig Isotopen-Und Medizintechnik GmbH

Radiology · 26d

Cleared Dec 30, 2003

ULTICARE DISPOSABLE SYRINGE 3 ML/CC

General Hospital · 25d

Cleared Dec 30, 2003

HYDROCOIL EMBOLIC SYSTEM (HES)

MicroVention, Inc.

Neurology · 20d

Cleared Dec 30, 2003

Ge Medical Systems F.I. Haifa

Radiology · 15d

Cleared Dec 30, 2003

GRI-BAG, GRI-BAG AP

Laboratorios Grifols, S.A.

General Hospital · 12d

Cleared Dec 29, 2003

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...

Beckman Coulter, Inc.

Immunology · 91d

Cleared Dec 29, 2003

VACUETTE QUICKSHIELD SAFETY TUBE HOLDER

Greiner Bio-One Vacuette North America

General Hospital · 56d

Cleared Dec 29, 2003

BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100

Bruno Independent Living Aids, Inc.

Physical Medicine · 20d

Cleared Dec 24, 2003

SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND...

Surgical Instruments Service and...

General & Plastic Surgery · 190d

Cleared Dec 24, 2003

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

Gen-Probe, Inc.

Microbiology · 159d

Cleared Dec 24, 2003

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

Immco Diagnostics, Inc.

Immunology · 126d

Cleared Dec 24, 2003

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4

Transphoton Corporation

Radiology · 90d

Cleared Dec 24, 2003

VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS

Varian Medical Systems

Radiology · 64d

Cleared Dec 24, 2003

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

Dade Behring, Inc.

Chemistry · 50d