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

72001–72024 of 176,076

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

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

Cleared Jul 30, 2003

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM

Respironics, Inc.

Anesthesiology · 63d

Cleared Jul 30, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...

Becton, Dickinson & CO

Microbiology · 58d

Cleared Jul 30, 2003

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN

Pasco Laboratories, Inc.

Microbiology · 57d

Cleared Jul 30, 2003

MR FIBER OPTIC ECG GATING SYSTEM

Sa Instruments, Inc.

Radiology · 56d

Cleared Jul 30, 2003

PEEK TETRIS SPINAL IMPLANT

Signus Medical, LLC

Orthopedic · 54d

Cleared Jul 30, 2003

VERTE-STACK SPINAL SYSTEM

Medtronic Sofamor Danek

Orthopedic · 50d

Cleared Jul 30, 2003

POWERHEART AED G3, MODEL 9300

Cardiac Science

Cardiovascular · 33d