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

71545–71568 of 175,468

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

Cleared Jul 17, 2003

GALT MEDICAL GUIDEWIRE

Galt Medical Corp.

Cardiovascular · 27d

Cleared Jul 17, 2003

RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA...

Rita Medical Systems, Inc.

General & Plastic Surgery · 24d

Cleared Jul 17, 2003

BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD

Baylis Medical Co., Inc.

General & Plastic Surgery · 23d

Cleared Jul 17, 2003

MODIFICATION TO HERMES O.R. CONTROL CENTER

Computer Motion, Inc.

General & Plastic Surgery · 22d

Cleared Jul 17, 2003

PHILLIPS OMNIDIAGNOST ELEVA

Philips Medical Systems, Inc.

Radiology · 15d

Cleared Jul 17, 2003

RADIUS 018 COUGAR WIRE

Radius Medical Technologies, Inc.

Cardiovascular · 7d

Cleared Jul 16, 2003

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

Acmi Corporation

Gastroenterology & Urology · 111d

Cleared Jul 16, 2003

BIO-LOGIC INSERT EARPHONES

Bio-Logic Systems Corp.

Ear, Nose, Throat · 78d

Cleared Jul 16, 2003

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES

Ge Medical Systems Information...

Cardiovascular · 76d

Cleared Jul 16, 2003

Immunostics Inc.,

Microbiology · 65d

Cleared Jul 16, 2003

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE

Trek Diagnostic Systems, Inc.

Microbiology · 61d

Cleared Jul 16, 2003

BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM

Becton, Dickinson & CO

Microbiology · 47d

Cleared Jul 16, 2003

AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL

Roche Diagnostics Corp.

Chemistry · 28d

Cleared Jul 16, 2003

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

Medical Analysis Systems, Inc.

Chemistry · 28d

Cleared Jul 16, 2003

OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

Olympus Optical Co., Ltd.

Gastroenterology & Urology · 9d

Cleared Jul 15, 2003

SAFETY INTRODUCER NEEDLE

B.Braun Medical, Inc.

Cardiovascular · 182d

Cleared Jul 15, 2003

B. BRAUN NERVE BLOCK CATHETER

B.Braun Medical, Inc.

General Hospital · 123d

Cleared Jul 15, 2003

PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE

Philips Medical Systems

Anesthesiology · 112d

Cleared Jul 15, 2003

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING...

The Binding Site, Ltd.

Immunology · 106d

Cleared Jul 15, 2003

ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR

Clinical Data, Inc.

Toxicology · 105d

Cleared Jul 15, 2003

MAYO CLINIC BC-10 1.5T

Mayo Medical Ventures

Radiology · 98d

Cleared Jul 15, 2003

ESTYLUS ELECTRIC MOTOR SYSTEM

Cleared Jul 15, 2003

ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM

Ortho Development Corp.

Orthopedic · 90d

Cleared Jul 15, 2003

SAFETY RELEASE ARCH BAR KIT

Casey Surgical, LLC