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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
41401–41424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2013
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
K123175 · KCT
Conmed Corporation
General Hospital · 135d
Cleared Feb 21, 2013
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
K123337 · OTO
Caldera Medical
Obstetrics & Gynecology · 113d
Cleared Feb 21, 2013
PEKKTON IVORY
K123638 · EBG
Cendres & Metaux SA
Dental · 87d
Cleared Feb 21, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR
K123651 · MBI
Pivot Medical
Orthopedic · 86d
Cleared Feb 21, 2013
COPRANCOLOR
K123680 · EIH
White Peaks Dental Systems GmbH & Co. KG
Dental · 83d
Cleared Feb 21, 2013
VITRO FIL LC
K123824 · EMA
Dfl Industria E Comercio SA
Dental · 71d
Cleared Feb 21, 2013
PERCUTANEOUS INTRODUCER KIT
K123974 · DYB
Teleflex, Inc.
Cardiovascular · 57d
Cleared Feb 21, 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT...
K123994 · LPL
Ciba Vision Corporation
Ophthalmic · 57d
Cleared Feb 21, 2013
VERIFICATION CONSOLE
K124002 · LHN
Varian Medical Systems
Radiology · 57d
Cleared Feb 21, 2013
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K124060 · DSI
Medicalgorithmics S.A.
Cardiovascular · 52d
Cleared Feb 21, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
K130038 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 45d
Cleared Feb 20, 2013
MDU5 PLUS STERILE BAG
K123424 · ITX
Boston Scientific Corp
Radiology · 105d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 20, 2013
SYNSPAR ADVANCED
K123613 · EIH
Ardent, Inc.
Dental · 89d
Cleared Feb 20, 2013
ARIX RAD ACQUISITION CONSOLE
K123650 · LLZ
Compania Mexicana DE Radiologia Cgr,...
Radiology · 85d
Cleared Feb 19, 2013
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
K110941 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 687d
Cleared Feb 19, 2013
COMMUNIFY PACS VIEWER
K120851 · LLZ
Communify Health, LLC
Radiology · 335d
Cleared Feb 19, 2013
DESARA SL
K121928 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 232d
Cleared Feb 19, 2013
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
K122477 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 189d
Cleared Feb 19, 2013
ARTAS SYSTEM FROM RESTORATION ROBOTICS
K123154 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 133d
Cleared Feb 19, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED,...
K123469 · LZA
Wear Safe (Malaysia) Sdn Bhd -...
General Hospital · 98d
Cleared Feb 19, 2013
MAMMOWORKSTATION
K123575 · LLZ
Image Diagnost International GmbH
Radiology · 91d
Cleared Feb 19, 2013
INTRADERMAL ADAPTER
K123588 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Feb 19, 2013
NEXUS RMGI
K123595 · EMA
Kerr Corporation
Dental · 90d