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

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175,820 results
45721–45744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Dec 12, 2011
ACCULIF TL CAGE
K113465 · MAX
Coalign Innovations, Inc.
Orthopedic · 20d
Cleared Dec 09, 2011
THE BUZZ FACIAL TONING SYSTEM
K102494 · NFO
Daka International , Ltd.
Neurology · 465d
Cleared Dec 09, 2011
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · KWQ
Genesys Spine
Orthopedic · 231d
Cleared CT Dec 09, 2011
PRESAGE ST2 ASSAY
K111452 · OYG
Critical Care Diagnostics, Inc. (Dba...
Chemistry · 198d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY...
K111830 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 09, 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · HWC
Globus Medical, Inc.
Orthopedic · 147d
Cleared Dec 09, 2011
SARN CENTRIFUGAL PUMP
K112229 · KFM
Terumo Cardiovascular Systems
Cardiovascular · 128d
Cleared Dec 09, 2011
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K112513 · LIT
Natec Medical , Ltd.
Cardiovascular · 101d
Cleared Dec 09, 2011
NETKONNECT REMOTE NETWORK EXTENSION
K112637 · MHX
Nihon Kohden
Cardiovascular · 91d
Cleared Dec 09, 2011
ACTIV VARNISH
K112946 · LBH
Pulpdent Corporation
Dental · 66d
Cleared Dec 09, 2011
RENOVIS CANNULATED SCREW SYSTEM
K113084 · HWC
Renovis Surgical Technologies, LLC
Orthopedic · 52d
Cleared Dec 09, 2011
ATB ADVANCE PTA DILATATION CATHETER
K113300 · LIT
Cook, Inc.
Cardiovascular · 30d
Cleared Dec 09, 2011
OSLEOBRIDGE IDSF SPACER CONECTOR
K113303 · HSB
Merete Medical GmbH
Orthopedic · 30d
Cleared Dec 09, 2011
EVOLUTION MP ADAPTIVE CS INSERT
K113325 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Dec 09, 2011
CANADY VIEIRA HYBRID PLASMA SCALPEL
K113500 · GEI
Us Medical Innovations, LLC
General & Plastic Surgery · 14d
Cleared Dec 08, 2011
SHIELD KYPHOPLASTY SYSTEM
K093477 · NDN
Soteira, Inc.
Orthopedic · 759d
Cleared Dec 08, 2011
PRESSON ELECTRODE
K103103 · GXZ
Persyst Development Corp.
Neurology · 414d
Cleared Dec 08, 2011
MODEL PM3030
K110068 · NUH
Omron Healthcare, Inc.
Neurology · 332d
Cleared Dec 08, 2011
AQUA LUBE
K110325 · NUC
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 308d
Cleared Dec 08, 2011
AIR-N-GO
K110379 · EFB
Satelec
Dental · 301d
Cleared Dec 08, 2011
BONE PLATE
K110926 · JEY
Biomaterials Korea, Inc.
Dental · 251d
Cleared Dec 08, 2011
VARILIFT CERVICAL INTERBODY FUSION SYSTEM
K111123 · ODP
Wenzel Spine
Orthopedic · 231d