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

71401–71424 of 175,468

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

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

Cleared Jul 30, 2003

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS

Image Analysis, Inc.

Radiology · 33d

Cleared Jul 30, 2003

8 CHANNEL CARDIAC PHASED ARRAY COIL

GE Medical Systems

Radiology · 28d

Cleared Jul 30, 2003

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES

Alliance Medical Corp.

Orthopedic · 28d

Cleared Jul 30, 2003

Aurora Imaging Technology, Inc.

Radiology · 23d

Cleared Jul 30, 2003

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC

Roche Diagnostics Corp.

Chemistry · 23d

Cleared Jul 29, 2003

REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE

Vivometrics, Inc.

Cardiovascular · 74d

Cleared Jul 29, 2003

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

Getinge USA, Inc.

General Hospital · 63d

Cleared Jul 29, 2003

BENCO SPHERICAL

Southern Dental Industries, Inc.