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

Filters: Cleared only ×
176,076 results
57769–57792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2007
IMAGECHECKER CT CAD SOFTWARE SYSTEM
K043617 · OEB
Hologic, Inc.
Radiology · 25d
Cleared Dec 21, 2007
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · GXY
Ge Healthcare
Neurology · 477d
Cleared Dec 21, 2007
LIFE4C
K063304 · LYX
Numedis, Inc.
Ophthalmic · 415d
Cleared Dec 21, 2007
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
K070458 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 308d
Cleared Dec 21, 2007
CAPILLARYS URINE (PN 2012)
K070486 · JKM
Sebia, Inc.
Immunology · 304d
Cleared Dec 21, 2007
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
K071375 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 219d
Cleared Dec 21, 2007
BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER...
K072068 · FRO
Bioartificial Gel Technologies...
General & Plastic Surgery · 147d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · LLH
bioMerieux, Inc.
Microbiology · 141d
Cleared Dec 21, 2007
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
K072328 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 123d
Cleared Dec 21, 2007
BODYFORM THORACIC FIXATION SYSTEM
K072407 · KWQ
Theken Spine, LLC
Orthopedic · 116d
Cleared Dec 21, 2007
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
K072475 · IPL
Etac Sverige AB
Physical Medicine · 108d
Cleared Dec 21, 2007
IRISPEC,CA/CB/CC
K072640 · JJW
Iris Diagnostics
Chemistry · 94d
Cleared Dec 21, 2007
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK...
K072784 · NBW
Taidoc Technology Corporation
Chemistry · 81d
Cleared Dec 21, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886 · DXT
Medrad, Inc.
Cardiovascular · 73d
Cleared Dec 21, 2007
DIMENSION VISTA C1 IN
K072965 · DBA
Dade Behring, Inc.
Immunology · 60d
Cleared Dec 21, 2007
3M ESPE LAVA CHAIRSIDE ORAL SCANNER
K073199 · NOF
Brontes Technologies
Dental · 38d
Cleared Dec 21, 2007
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
K073399 · FCG
Envisioneering, LLC
Radiology · 17d
Cleared Dec 20, 2007
DEPUY LPS DISTAL FEMORAL COMPONENT
K063686 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 373d
Cleared Dec 20, 2007
BD GENEOHM STAPHSR ASSAY
K071026 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 253d
Cleared Dec 20, 2007
LINASYS
K071063 · OEW
Pathfinder Therapeutics, Inc.
General & Plastic Surgery · 248d
Cleared Dec 20, 2007
MICROFUSE BONE VOID FILLER
K071187 · MQV
Globus Medical, Inc.
Orthopedic · 234d
Cleared Dec 20, 2007
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · GXD
Synergetics, Inc.
Neurology · 204d
Cleared Dec 20, 2007
ENVOY 500 HDL
K071706 · LBS
Clinical Data, Inc.
Chemistry · 182d
Cleared Dec 20, 2007
STUDIODOP VICORDER
K071730 · JOP
Skidmore Medical, Limited
Cardiovascular · 178d