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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
64921–64944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2005
SOMATOM DEFINITION
K052216 · JAK
Siemens Medical Systems, Inc.
Radiology · 36d
Cleared Sep 08, 2005
SUPERDIMENSION/BRONCHUS 4.1
K052260 · JAK
Superdimension, Ltd.
Radiology · 20d
Cleared Sep 08, 2005
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
K052305 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Sep 08, 2005
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33
K052337 · LLZ
Eizo Nanao Corporation
Radiology · 13d
Cleared Sep 07, 2005
UNIPLAIN & UNICHROM
K042287 · GAL
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 379d
Cleared Sep 07, 2005
BIO-STIM KIT
K050174 · GZJ
Skylark Device & Systems Co., Ltd.
Neurology · 225d
Cleared Sep 07, 2005
REFIX INTERNAL FRACTURE FIXATION SCREWS
K050388 · HWC
Xtremi-T, LLC
Orthopedic · 204d
Cleared Sep 07, 2005
WHITTLESTONE EXPRESSER
K051112 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 128d
Cleared Sep 07, 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 114d
Cleared Sep 07, 2005
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K051279 · BZK
Caldyne, Inc.
General Hospital · 113d
Cleared Sep 07, 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K051716 · KWP
Vertebron, Inc.
Orthopedic · 72d
Cleared Sep 07, 2005
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
K051831 · GEI
Applied Surgical, LLC
General & Plastic Surgery · 63d
Cleared Sep 07, 2005
EUGENONE
K051952 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 51d
Cleared Sep 07, 2005
FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE...
K051966 · DKZ
Worldwide Medical, LLC
Toxicology · 49d
Cleared Sep 07, 2005
NSTRAND IMPLANTATION KIT
K052024 · KXK
North American Scientific, Inc.
Radiology · 43d
Cleared Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
K052078 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 37d
Cleared Sep 07, 2005
CONNEXUS, .5CC, MODEL 023000-005
K052098 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 35d
Cleared Sep 07, 2005
AIDA COMPACT II SYSTEM
K052159 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 29d
Cleared Sep 06, 2005
E-STIM II
K050435 · GZJ
Lhasa Oms, Inc.
Neurology · 196d
Cleared Sep 06, 2005
PRAXAIR MEDICAL AIR MIXER
K051192 · BZR
Praxair, Inc.
Anesthesiology · 119d
Cleared Sep 06, 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · LPH
Exactech, Inc.
Orthopedic · 85d
Cleared Sep 06, 2005
F-400 SYSTEM
K051585 · GCJ
Mauna Kea Technologies
General & Plastic Surgery · 83d
Cleared Sep 06, 2005
MBARESORB IMPLANT
K051611 · HWC
Kinetikos Medical, Inc.
Orthopedic · 81d
Cleared Sep 06, 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051616 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 81d