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
35929–35952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155 · LBH
Johnson & Johnson Healthcare...
Dental · 87d
Cleared CT Jan 29, 2015
Capillus 272 Pro
K143199 · OAP
Capillus, LLC
General & Plastic Surgery · 84d
Cleared Jan 29, 2015
Ultimax-i
K143281 · OWB
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Jan 29, 2015
LOGIQ P9, LOGIQ P7
K143452 · IYN
Ge Healthcare
Radiology · 58d
Cleared Jan 28, 2015
WINSIX Implant System
K133733 · DZE
Biosaf IN S.R.L.
Dental · 418d
Cleared Jan 28, 2015
DCCERAM SYSTEM
K141400 · EIH
Ceramay GmbH & Co.Kg
Dental · 245d
Cleared Jan 28, 2015
QK-SYSTEMIC THERAPEUTIC APPARATUS
K141892 · ILY
Harbin Quanke Medi-Technical...
Physical Medicine · 198d
Cleared Jan 28, 2015
S22 Digital Color Doppler Ultrasound System
K142815 · IYN
Sonoscape Company Limited
Radiology · 121d
Cleared Jan 28, 2015
Endoskeleton TCS System
K142940 · OVE
Titan Spine, LLC
Orthopedic · 111d
Cleared Jan 28, 2015
Klassic BiPolar System
K143113 · KWY
Total Joint Orthopedics
Orthopedic · 90d
Cleared Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
K143691 · LBR
Roche Diagnostics Operations (Rdo)
Chemistry · 35d
Cleared Jan 27, 2015
NAUTILUS DELTA
K141634 · LJS
Romedex International Srl
General Hospital · 223d
Cleared Jan 27, 2015
SCHOELLY SINUSCOPE
K142249 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 166d
Cleared Jan 27, 2015
PANAVIA SA Cement Plus Automix
K142625 · EMA
Kuraray Noritake Dental, Inc.
Dental · 133d
Cleared Jan 27, 2015
AliveCor Heart Monitor
K142743 · DXH
AliveCor, Inc.
Cardiovascular · 125d
Cleared Jan 27, 2015
Celerity PICC Tip Confirmation System
K142889 · LJS
AngioDynamics, Inc.
General Hospital · 116d
Cleared Jan 27, 2015
Ligasure Blunt Tip Sealer/Divider
K142929 · GEI
Covidien
General & Plastic Surgery · 110d
Cleared Jan 27, 2015
Stryker SonicPin System, Stryker SonicAnchor System
K143063 · HTY
Stryker Trauma GmbH
Orthopedic · 95d
Cleared Jan 27, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone...
K143187 · DJG
Healgen Scientific, LLC
Chemistry · 83d
Cleared Jan 27, 2015
Wound Matrix TF
K143426 · KGN
Miromatrix Medical, Inc.
General & Plastic Surgery · 57d
Cleared Jan 27, 2015
MasterSL femoral stem
K143509 · LZO
Lima Corporate S.P.A.
Orthopedic · 47d
Cleared Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
K143680 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 34d
Cleared Jan 26, 2015
CROC
K141685 · DXC
Combat Medical Systems, LLC
Cardiovascular · 217d
Cleared Jan 26, 2015
LEVA (TM) SPACER SYSTEM
K141980 · MAX
Spine Wave, Inc.
Orthopedic · 189d