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
39577–39600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2013
LIGAPASS
K132395 · OWI
Medicrea International
Orthopedic · 127d
Cleared CT Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA...
K132429 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 06, 2013
PIEZON 250
K132445 · ELC
E.M.S Electro Medical Systems S.A
Dental · 122d
Cleared Dec 06, 2013
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
K132519 · JEY
Stryker
Dental · 116d
Cleared Dec 06, 2013
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
K132967 · BZD
3B Medical, Inc.
Anesthesiology · 77d
Cleared Dec 06, 2013
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
K133029 · DXC
Compression Works, LLC
Cardiovascular · 71d
Cleared Dec 06, 2013
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K133043 · LIT
Angioslide, Ltd.
Cardiovascular · 71d
Cleared Dec 06, 2013
STAXX(R) SYSTEM
K133207 · MQP
Spine Wave, Inc.
Orthopedic · 49d
Cleared Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · GAW
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared CT Dec 06, 2013
CROSSTREES PVA POD
K133372 · NDN
Crosstrees Medical, Inc.
Orthopedic · 35d
Cleared Dec 05, 2013
BOND APATITE
K121177 · LYC
Augma Biomaterials, Ltd.
Dental · 596d
Cleared Dec 05, 2013
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K130467 · MBI
MedShape, Inc.
Orthopedic · 283d
Cleared Dec 05, 2013
CAPELLA
K130788 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 258d
Cleared Dec 05, 2013
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
K131095 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 231d
Cleared Dec 05, 2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
K131229 · OTN
American Medical Systems
Gastroenterology & Urology · 219d
Cleared Dec 05, 2013
MCKESSON CARDIOLOGY HEMO
K131497 · MWI
Mckesson Israel , Ltd.
Cardiovascular · 195d
Cleared Dec 05, 2013
UD IMPLANT SYSTEM
K131682 · DZE
Medimecca Co., Ltd.
Dental · 178d
Cleared Dec 05, 2013
TFCC FAST-FIX KIT
K132079 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 153d
Cleared Dec 05, 2013
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082 · MST
Aesku Diagnostics
Immunology · 153d
Cleared Dec 05, 2013
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153 · FOZ
Nipro Medical Corporation
General Hospital · 146d
Cleared Dec 05, 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
K132285 · PHX
Tornier S.A.S.
Orthopedic · 135d
Cleared Dec 05, 2013
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · HSX
Conformis, Inc.
Orthopedic · 104d
Cleared Dec 05, 2013
ZIEHM VISION RFD
K132904 · JAA
Ziehm Imaging GmbH
Radiology · 80d
Cleared Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
K132966 · NBW
Infopia Co, Ltd.
Chemistry · 76d