Search FDA 510(k) Database

7,139 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21529–21552 of 174,061
Cleared Apr 12, 2019
MIS Bunion Plating System
K190658 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 29d
Cleared Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K190664 · MUJ
Brainlab AG
Radiology · 28d
Cleared Apr 11, 2019
Syntec Femoral Nail System
K181296 · HSB
Syntec Scientific Corporation
Orthopedic · 330d
Cleared Apr 11, 2019
Brux Night Guard
K181361 · MQC
Brux Night Guard
Dental · 323d
Cleared Apr 11, 2019
ELRA Electrode
K181758 · KNS
Starmed Co., Ltd.
Gastroenterology & Urology · 283d
Cleared Apr 11, 2019
Endoform Restella
K183398 · FTM
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 125d
Cleared Apr 11, 2019
Codman Electrosurgical Generator, Foot Pedal
K183526 · GEI
Kls Martin GmbH + Co. KG
Neurology · 113d
Cleared Apr 11, 2019
PureSleep (OTC use)
K190058 · LRK
Sleep Science Partners, Inc.
Dental · 90d
Cleared Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
K190070 · LFL
Stryker Corporation
General & Plastic Surgery · 86d
Cleared Apr 11, 2019
Zavation Spinal System
K190317 · NKB
Zavation Medical Products, LLC
Orthopedic · 57d
Cleared Apr 11, 2019
VisCalor bulk
K190453 · EBF
Voco GmbH
Dental · 45d
Cleared Apr 11, 2019
Eye Prime
K190786 · IYO
Ellex Medical Pty, Ltd.
Radiology · 15d
Cleared Apr 10, 2019
PROPHYflex 4
K181110 · EFB
Kaltenbach & Voigt GmbH
Dental · 348d
Cleared Apr 10, 2019
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · SCL
Allergy & Applicator Depot, LLC
General Hospital · 203d
Cleared Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662 · PDQ
Boston Endo Surgical Tech,
Neurology · 197d
Cleared Apr 10, 2019
PUMA-G System
K183057 · KGC
Coaptech, LLC
Gastroenterology & Urology · 159d
Cleared Apr 10, 2019
GLUCOCARD® W onyx Blood Glucose Monitoring System
K183306 · NBW
Arkray Factory, Inc.
Chemistry · 133d
Cleared Apr 10, 2019
S-MAK XL
K190175 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared Apr 10, 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 58d
Cleared Apr 10, 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · NKG
Medacta International S.A.
Orthopedic · 29d
Cleared Apr 09, 2019
Transtek Blood Pressure Monitor
K181832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 274d
Cleared Apr 09, 2019
Vera
K182333 · LXJ
Reflexion Health, Inc.
Physical Medicine · 224d
Cleared Apr 09, 2019
Pantheris SV
K182341 · MCW
Avinger, Inc.
Cardiovascular · 224d
Cleared Apr 09, 2019
Adult Intraosseous Infusion Device
K182770 · FMI
Einstein Works, LLC
General Hospital · 193d