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
61561–61584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2006
MODIFICATION TO STOCKERT S5 SYSTEM
K062396 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 43d
Cleared Sep 28, 2006
MODIFICATION TO LUCAS
K062401 · DRM
Jolife AB
Cardiovascular · 43d
Cleared Sep 28, 2006
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K062451 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 37d
Cleared Sep 28, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · MUJ
Accuray Incorporated
Radiology · 31d
Cleared Sep 28, 2006
CARE-E-VAC 3
K062610 · BTA
Ohio Medical Corporation
General & Plastic Surgery · 23d
Cleared Sep 27, 2006
TATTOOSTAR FAMILY
K060787 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 188d
Cleared Sep 27, 2006
EPOC BLOOD ANALYSIS SYSTEM
K061597 · JGS
Epocal, Inc.
Chemistry · 111d
Cleared Sep 27, 2006
LITETOUCH DENTAL LASER SYSTEM
K061966 · GEX
Light Instrument, Ltd.
General & Plastic Surgery · 77d
Cleared Sep 27, 2006
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · DXT
Toshiba America Medical Systems, In.C
Radiology · 76d
Cleared Sep 27, 2006
CHASE CARDIAC ANALYSIS SYSTEM
K062031 · LLZ
Chase Medical, LP
Radiology · 71d
Cleared Sep 27, 2006
MOLTENO3
K062252 · KYF
Iop, Inc.
Ophthalmic · 55d
Cleared Sep 27, 2006
KOWA NONMYD ALPHA-D
K062356 · HKI
Kowa Co. , Ltd.
Ophthalmic · 44d
Cleared Sep 27, 2006
CLEARFIL DC BOND
K062382 · KLE
Kuraray Medical, Inc.
Dental · 43d
Cleared Sep 27, 2006
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
K062385 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 43d
Cleared Sep 27, 2006
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE,...
K062429 · DTM
Edwards Lifesciences Research Medical
Cardiovascular · 37d
Cleared Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K062599 · JXG
Integra LifeSciences Corporation
Neurology · 26d
Cleared Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679 · HWC
Arthrex, Inc.
Orthopedic · 19d
Cleared Sep 27, 2006
OWL URF-3AP
K062758 · GXD
Diros Technology, Inc.
Neurology · 12d
Cleared Sep 26, 2006
MAGSTIM 200-2
K060847 · GWF
Magstim Company Us, LLC
Neurology · 182d
Cleared Sep 26, 2006
ISS INTEGRATED SPINE SYSTEM
K061524 · MNH
Ortho Development Corp.
Orthopedic · 116d
Cleared Sep 26, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K062133 · MQP
Medtronic Spinal and Biologics Div
Orthopedic · 62d
Cleared Sep 26, 2006
CLEARFIL ESTHETIC CEMENT & DC BOND
K062410 · EMA
Kuraray Medical, Inc.
Dental · 40d
Cleared Sep 26, 2006
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
K062505 · MNI
Abbott Spine, Inc.
Orthopedic · 29d
Cleared Sep 25, 2006
23 MM SINGLE-PEG PATELLA COMPONENT
K061340 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 133d