FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,468 results

70417–70440 of 175,468

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

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

Cleared Oct 30, 2003

GLOBAL PRESS-FIT STEM

Global Medical Co.

Orthopedic · 87d

Cleared Oct 30, 2003

A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS

A&D Engineering, Inc.

Cardiovascular · 78d

Cleared Oct 30, 2003

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION

Ge Medical Systems Information...

Cardiovascular · 77d

Cleared Oct 30, 2003

GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

Ge Med. Systems Ultrasound & Prim....

Radiology · 63d

Cleared Oct 30, 2003

ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP...

Ethicon Endo-Surgery, Inc.

General & Plastic Surgery · 62d

Cleared Oct 30, 2003

MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS

Turbo Wheelchair Co., Inc.

Physical Medicine · 57d

Cleared Oct 30, 2003

GLYCOHEMOSURE HBA1C CONTROL

Quantimetrix Corp.

Chemistry · 52d

Cleared Oct 30, 2003

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...

Dade Behring, Inc.

Chemistry · 51d