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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

70873–70896 of 174,955

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

Cleared Aug 01, 2003

Syneron Medical, Ltd.

General & Plastic Surgery · 35d

Cleared Aug 01, 2003

MODIFICATION TO THERMACOOL TC SYSTEM

General & Plastic Surgery · 25d

Cleared Aug 01, 2003

TERUMO AL8X ARTERIAL FILTER WITH X-COATING

Terumo Cardiovascular Systems Corp.

Cardiovascular · 22d

Cleared Aug 01, 2003

IQ HYDROPHILIC GUIDE WIRE

Boston Scientific Corp

Cardiovascular · 15d

Cleared Aug 01, 2003

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I

Planar Systems, Inc.

Radiology · 14d

Cleared Jul 31, 2003

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

Organ Recovery Systems, Inc.

Gastroenterology & Urology · 457d

Cleared Jul 31, 2003

MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F...

Medtronic Vascular

Cardiovascular · 150d

Cleared Jul 31, 2003

Wheelchair & Scooter Express

Physical Medicine · 142d

Cleared Jul 31, 2003

KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320

Kuann Dah Industry Co., Ltd.

Physical Medicine · 98d

Cleared Jul 31, 2003

RSV (RADIOLOGY SYSTEM VISIODENT

Radiology · 85d

Cleared Jul 31, 2003

GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT

Howmedica Osteonics Corp.

Orthopedic · 80d

Cleared Jul 31, 2003

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

Surgitech, Inc.

Physical Medicine · 72d

Cleared Jul 31, 2003

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...

Dade Behring, Inc.

Microbiology · 71d

Cleared Jul 31, 2003

FILMLESS CLINIC

Connect Imaging, Inc.

Radiology · 59d

Cleared Jul 31, 2003

HEMOSIL FACTOR IX DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 48d

Cleared Jul 31, 2003

SHOCKWAVE SUSPENSION WHEELCHAIR

Per4max Medical, LLC

Physical Medicine · 21d

Cleared Jul 31, 2003

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

Nichols Institute Diagnostics

Chemistry · 14d

Cleared Jul 30, 2003

EARLYDETECT MENOPAUSE TEST FOR FSH

Early Detect, Inc.

Chemistry · 204d

Cleared Jul 30, 2003

NIAGARA TEMPORARY DUAL LUMEN CATHETERS

C.R. Bard, Inc.

Gastroenterology & Urology · 184d

Cleared Jul 30, 2003

SAUFLON MULTIPURPOSE SOLUTION - NO RUB

Sauflon Pharmaceuticals, Ltd.

Ophthalmic · 184d

Cleared Jul 30, 2003

Viasys Healthcare GmbH

Anesthesiology · 105d

Cleared Jul 30, 2003

UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

Orthopedic · 90d

Cleared Jul 30, 2003

MINI STATCO2 CO2 DETECTOR, MODEL 10-55371

Mercury Medical

Anesthesiology · 86d

Cleared Jul 30, 2003

CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001

Scantibodies Laboratory, Inc.

Chemistry · 75d