Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×

176,076 results

70441–70464 of 176,076

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

Cleared Jan 02, 2004

HEMOSIL LIQUID ANTITHROMBIN XL

Instrumentation Laboratory CO

Hematology · 30d

Cleared Jan 02, 2004

OMNILINK .018 BILIARY STENT SYSTEM

Gastroenterology & Urology · 23d

Cleared Dec 31, 2003

GEN-PROBE APTIMA COMBO 2 ASSAY

Gen-Probe, Inc.

Microbiology · 134d

Cleared Dec 31, 2003

KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)

Imaging Therapeutics, Inc.

Orthopedic · 85d

Cleared Dec 31, 2003

AMS LARGE PORE POLYPROPYLENE MESH

American Medical Systems, Inc.

Obstetrics & Gynecology · 42d

Cleared Dec 31, 2003

GORE BIOABSORBABLE MESH

W.L. Gore & Associates, Inc.

General & Plastic Surgery · 37d

Cleared Dec 31, 2003

BIOANCHOR WITH DISPOSABLE DRIVER

Orthopedic · 23d

Cleared Dec 30, 2003

HEMEDEX FIXATION DEVICE

Hemedex Incorporated

Gastroenterology & Urology · 173d

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