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

71977–72000 of 174,955

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

Cleared Apr 01, 2003

SUPEROPEN 0.35T, MODEL NSM-P035

Neusoft Digital Medical Systems Co.,...

Radiology · 8d

Cleared Apr 01, 2003

RITA CLIPS FOR INFUSION PUMPS

Rita Medical Systems, Inc.

General Hospital · 7d

Cleared Mar 31, 2003

VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

Gish Biomedical, Inc.

Cardiovascular · 174d

Cleared Mar 31, 2003

VBL SERUM TROPONIN I TEST, MODEL 1001

Vancouver Biotech , Ltd.

Chemistry · 164d

Cleared Mar 31, 2003

GISH ARTERIAL FILTER WITH GBS COATING

Gish Biomedical, Inc.

Cardiovascular · 133d

Cleared Mar 31, 2003

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

Pointe Scientific, Inc.,

Chemistry · 117d

Cleared Mar 31, 2003

CANDELA GENTLE LASE FAMILY OF LASER SYSTEM

General & Plastic Surgery · 90d

Cleared Mar 31, 2003

ITI DENTAL IMPLANT SYSTEM

Cleared Mar 31, 2003

JOSTENT SELFX, MODELS 015SX4406

Gastroenterology & Urology · 98d

Cleared Mar 31, 2003

IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP,...

Cardiovascular · 74d

Cleared Mar 31, 2003

CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5

Microgenics Corp.

Toxicology · 33d

Cleared Mar 31, 2003

SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL...

Power Medical Interventions, Inc.

General & Plastic Surgery · 28d

Cleared Mar 31, 2003

QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

Ballard Medical Products

General & Plastic Surgery · 24d

Cleared Mar 28, 2003

REPROCESSED PULSE OXIMETER SENSORS

Sterilmed, Inc.

Anesthesiology · 591d

Cleared Mar 28, 2003

MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C

Aomori Olympus Co., Ltd.

Ear, Nose, Throat · 246d

Cleared Mar 28, 2003

BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE

Blackstone Medical, Inc.

Orthopedic · 203d

Cleared Mar 28, 2003

SEEDLINKS, MODELS 70301, 70302, 70303

Sourcetech Medical, LLC

Radiology · 183d

Cleared Mar 28, 2003

ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX

General & Plastic Surgery · 179d

Cleared Mar 28, 2003

Anesthesiology · 156d

Cleared Mar 28, 2003

RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS

Anesthesiology · 123d

Cleared Mar 28, 2003

EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

Hypoguard USA, Inc.

Chemistry · 88d

Cleared Mar 28, 2003

Interacoustics A/S, Assens

Ear, Nose, Throat · 85d

Cleared Mar 28, 2003

VERMED A10021 RESTING EKG TAB ELECTRODE

Vermont Medical, Inc.

Cardiovascular · 79d

Cleared Mar 28, 2003

LAWRENCE CSERION, MODEL CS-1

Radiology · 71d