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
76009–76032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Sulzer Spine-Tech
Orthopedic · 24d
Cleared Feb 15, 2002
A1CNOW FOR RX HOME USE
K020234 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
K020235 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
PARAGON INFUSION SYSTEM
K020251 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385 · JAK
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Feb 14, 2002
GINDA GUARD
K011239 · EBD
Cosmedent, Inc.
Dental · 297d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · FFL
Sterilmed, Inc.
Gastroenterology & Urology · 189d
Cleared Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
K012685 · NLW
Sterilmed, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 14, 2002
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · KLE
Jeneric/Pentron, Inc.
Dental · 120d