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

71017–71040 of 176,076

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

Cleared Oct 31, 2003

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

Dade Behring, Inc.

Chemistry · 72d

Cleared Oct 31, 2003

VITEK GRAM NEGATIVE GATIFLOXACIN

bioMerieux, Inc.

Microbiology · 59d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

bioMerieux, Inc.

Microbiology · 57d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE LINEZOLID

bioMerieux, Inc.

Microbiology · 56d

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

Ortho-Clinical Diagnostics, Inc.

Microbiology · 36d

Cleared Oct 31, 2003

MODIFICATION TO GLOBALCARDIO

Cardiocomm Solutions, Inc.

Cardiovascular · 32d

Cleared Oct 31, 2003

IONOFIL COLOR AC

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

Ortho-Clinical Diagnostics

Microbiology · 31d

Cleared Oct 31, 2003

PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

Osypka Medical, Inc.

Cardiovascular · 31d

Cleared Oct 31, 2003

FUKUDA DENSHI MODEL FF SONIC UF-750XT

Fukuda Denshi USA, Inc.

Radiology · 28d

Cleared Oct 31, 2003

PHERON PTA CATHETER

Biotronik, Inc.

Cardiovascular · 28d

Cleared Oct 31, 2003

K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT

Track Corporation

Physical Medicine · 22d

Cleared Oct 31, 2003

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL...

Medtronic Perfusion Systems

Cardiovascular · 22d

Cleared Oct 31, 2003

INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM

Draeger Medical Systems, Inc.

Cardiovascular · 17d

Cleared Oct 30, 2003

DBB-05 HEMODIALYSIS DELIVERY SYSTEM

Davita Clinical Research (Trri)

Gastroenterology & Urology · 377d

Cleared Oct 30, 2003

POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851

Richard Wolf Medical Instruments Corp.

Orthopedic · 294d

Cleared Oct 30, 2003

RATIONAL IMAGING PACS

Intuitive Imaging Informatics, LLC

Radiology · 174d

Cleared Oct 30, 2003

STERISIL ANTIMICROBIAL TUBING AND BOTTLE

Cleared Oct 30, 2003

TOPKIN WOUND DRESSING

Biomet Merck GmbH

General & Plastic Surgery · 153d

Cleared Oct 30, 2003

DIO-DENT 10 DENTAL DIODE LASER

Msq (M2) , Ltd.

General & Plastic Surgery · 140d

Cleared Oct 30, 2003

PROFUSION BONE VOID FILLER KIT

Orthopedic · 136d

Cleared Oct 30, 2003

FERTELL FEMALE FERTILITY TEST

Chemistry · 125d

Cleared Oct 30, 2003

ENDOHELIX ENDARTERECTOMY DEVICE

Cardiovascular · 114d

Cleared Oct 30, 2003

BONESOURCE HAC FAST SETTING CEMENT

Stryker Instruments

Neurology · 90d