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

119689–119712 of 174,955

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

Cleared Sep 25, 1991

AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER

United States Surgical, A Division of...

General & Plastic Surgery · 68d

Cleared Sep 25, 1991

LIPID LINEARITY CONTROLS

Creative Laboratory Products, Inc.

Chemistry · 68d

Cleared Sep 25, 1991

QUANTIMETRIX AMMONIA CONTROLS

Quantimetrix Corp.

Chemistry · 61d

Cleared Sep 25, 1991

RAICHEM(TM) CREATINE KINASE-MB REAGENT

Reagents Applications, Inc.

Chemistry · 57d

Cleared Sep 25, 1991

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT

Roche Diagnostic Systems, Inc.

Toxicology · 62d

Cleared Sep 25, 1991

THE E TEST, MODIFICATION

Microbiology · 51d

Cleared Sep 25, 1991

O.R. Concepts, Inc.

General & Plastic Surgery · 49d

Cleared Sep 25, 1991

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III

Analytical Control Systems, Inc.

Toxicology · 37d

Cleared Sep 25, 1991

SELF-CONTAINED SURGICAL SLUSH FREEZER

Chemistry · 42d

Cleared Sep 25, 1991

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL

Hichem Diagnostics

Chemistry · 33d

Cleared Sep 25, 1991

URINE AMPHETAMINE DIRECT RIA KIT (I-125)

Immunalysis Corporation

Toxicology · 29d

Cleared Sep 25, 1991

B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES

Bd Becton Dickinson Vacutainer...

General Hospital · 26d

Cleared Sep 25, 1991

HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER

Heraeus Lasersonics, Inc.

General & Plastic Surgery · 22d

Cleared Sep 25, 1991

WILTEK ELECTROCAUTERY ADAPTOR

Wiltek Medical, Inc.

General & Plastic Surgery · 12d

Cleared Sep 25, 1991

WILTEK ELECTROCAUTERY ACTIVE CORD

Wiltek Medical, Inc.

General & Plastic Surgery · 12d

Cleared Sep 24, 1991

PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER

Mill-Rose Laboratory

Ear, Nose, Throat · 228d

Cleared Sep 24, 1991

OPTICAL CATHETER ARTHROSCOPE

Medical Dynamics, Inc.

Orthopedic · 183d

Cleared Sep 24, 1991

DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES

Exmoor Plastics , Ltd.

Ear, Nose, Throat · 174d

Cleared Sep 24, 1991

UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR

Personal Products Co.

Obstetrics & Gynecology · 105d

Cleared Sep 24, 1991

CARDIOTRACE CARDIAC EVALUATION SYSTEMS

Cine Graphics, Inc.

Radiology · 90d

Cleared Sep 24, 1991

FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE

Orthopedic · 90d

Cleared Sep 24, 1991

FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-

General Hospital · 89d

Cleared Sep 24, 1991

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET

Radiology · 75d

Cleared Sep 24, 1991

JAMIESON JT-CRP CINE FILM PROCESSOR

Jamieson Film Co.

Radiology · 64d