Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
41977–42000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2013
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
K123459 · MBH
Zimmer, Inc.
Orthopedic · 105d
Cleared Feb 22, 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615 · EIH
Dentsply Intl.
Dental · 91d
Cleared Feb 22, 2013
EMORY CARDIAC TOOLBOX 4.0
K123646 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · MOS
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Feb 22, 2013
EOS
K123740 · MQB
Eos Imaging
Radiology · 79d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Feb 22, 2013
MRI PATIENT MONITORING SYSTEM (MODEL 865214)
K124061 · MWI
Invivo Corporation
Cardiovascular · 53d
Cleared Feb 22, 2013
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
K130058 · IYN
Olympus Medical Systems Corp.
Radiology · 44d
Cleared Feb 22, 2013
PERSONA NATURAL TIBIA BASEPLATES
K130143 · JWH
Zimmer, Inc.
Orthopedic · 31d
Cleared Feb 21, 2013
COMFORT COUGH
K113549 · NHJ
Seoil Pacific Corp.
Anesthesiology · 448d
Cleared Feb 21, 2013
FIN-S MICROIMPLANT
K120861 · OAT
Creekside Orthodontics
Dental · 336d
Cleared Feb 21, 2013
FIBER DISK AND BLOCK PERMANENT, TRINIA
K121735 · EBF
Bioloren S.R.L.
Dental · 253d
Cleared Feb 21, 2013
EMBLETTA MPR
K122516 · MNR
Embla Systems
Anesthesiology · 188d
Cleared Feb 21, 2013
LUCENT
K122967 · MAX
Spinal Elements, Inc.
Orthopedic · 149d
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