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
37345–37368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2014
LEICA FL800
K141136 · IZI
Leica Biosystems Richmond
Radiology · 110d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · JJX
Siemens Healthcare Diagnostics, Inc.
Microbiology · 49d
Cleared Aug 19, 2014
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
K141979 · OWB
Philips Medical Systems Netherland BV
Radiology · 29d
Cleared Aug 19, 2014
M.U.S.T PEDICLE SCREW SYSTEM
K141988 · NKB
Medacta International
Orthopedic · 28d
Cleared Aug 18, 2014
PHYSIOGLOVE ET SYSTEM
K133703 · DXH
Commwell R&D , Ltd.
Cardiovascular · 258d
Cleared Aug 18, 2014
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330 · KKX
3M Healthcare
General Hospital · 189d
Cleared Aug 18, 2014
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
K140585 · OJP
Curexo Technology Corporation
Orthopedic · 164d
Cleared Aug 18, 2014
M.U.S.T. EXTENSION
K141044 · NKB
Medacta International
Orthopedic · 117d
Cleared Aug 18, 2014
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K141352 · KJJ
Oculus Innovative Sciences
Dental · 87d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · LZO
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 18, 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
K141769 · DQO
Lightlab Imaging, Inc.
Cardiovascular · 48d
Cleared Aug 18, 2014
SOLUTION SET/EXTENSION SET
K142011 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Aug 17, 2014
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
K132518 · OHT
Wellquest Intl., Inc.
General & Plastic Surgery · 370d
Cleared Aug 15, 2014
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
K132049 · NKB
Choicespine
Orthopedic · 409d
Cleared Aug 15, 2014
HEMOSIL D-DIMER HS 500 CONTROL
K133582 · GGN
Instrumentation Laboratory
Hematology · 267d
Cleared CT Aug 15, 2014
AVACEN 100
K133981 · IRT
Avacen, Inc.
Physical Medicine · 232d
Cleared Aug 15, 2014
CORMATRIX PROTECT ECM ENVELOPE
K140306 · FTM
Cormatrix Cardiovascular, Inc.
General & Plastic Surgery · 189d
Cleared Aug 15, 2014
MASTERSURG / EXPERTSURG
K140308 · EBW
Kaltenbach & Voigt GmbH
Dental · 189d
Cleared Aug 15, 2014
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
K140366 · GEX
Hogue Surgical, LLC
General & Plastic Surgery · 182d
Cleared Aug 15, 2014
RESPICONNECT ADAPTER
K140919 · CAF
Trudell Medical Int'L
Anesthesiology · 127d
Cleared Aug 15, 2014
ALIVECOR HEART MONITOR
K140933 · DXH
AliveCor, Inc.
Cardiovascular · 126d
Cleared Aug 15, 2014
VONFLEX S BITE
K140966 · ELW
Vericom Co., Ltd.
Dental · 122d
Cleared Aug 15, 2014
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · LOX
Medtronic, Inc.
Cardiovascular · 109d
Cleared Aug 15, 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · ODP
Exactech, Inc.
Orthopedic · 106d