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
76513–76536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
K013874 · CEP
Unipath , Ltd.
Chemistry · 90d
Cleared Feb 19, 2002
PRIME-DENT HEMA DESENSITIZER
K013970 · EBF
Prime Dental Manufacturing, Inc.
Dental · 78d
Cleared Feb 19, 2002
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
K014167 · NBW
Polymedica Pharmaceuticals, U.S.A.,...
Chemistry · 62d
Cleared Feb 19, 2002
MEDSURG EQUIPMENT COVERS
K014239 · MMP
International Medsurg Connection
General Hospital · 55d
Cleared Feb 19, 2002
JETPOLISHER
K014249 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
JETSTREAM
K014252 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Feb 19, 2002
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · EKZ
Diagnostic Data, Inc.
Dental · 41d
Cleared Feb 19, 2002
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Feb 19, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64...
K020328 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 15, 2002
CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)
K011147 · EHD
Cavitat Medical Technologies, Inc.
Radiology · 305d
Cleared Feb 15, 2002
MB 103 MILLENNIUM BLADES
K011833 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 248d
Cleared Feb 15, 2002
VCS-A SERIES CLAMP
K011863 · DXC
Vascular Control Systems, Inc.
Radiology · 246d
Cleared Feb 15, 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE...
K012472 · DXN
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Feb 15, 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · EZL
Sewoon Medical Co., Ltd.
Gastroenterology & Urology · 137d
Cleared Feb 15, 2002
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
K013342 · CGA
Chay Medical, LLC
Chemistry · 129d
Cleared Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
K013397 · JIX
Fisher Diagnostics
Hematology · 123d
Cleared Feb 15, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K013825 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Feb 15, 2002
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
K014005 · GCJ
Apple Medical Corp.
General & Plastic Surgery · 72d
Cleared Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
K014173 · DKJ
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Feb 15, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
K014284 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 50d
Cleared Feb 15, 2002
MB 102 MILLENNIUM BLADES
K020122 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 32d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d