Search FDA 510(k) Database

7,055 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19801–19824 of 174,061
Cleared Nov 14, 2019
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · OWQ
Sterilmed, Inc.
Cardiovascular · 260d
Cleared Nov 14, 2019
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip...
K190522 · MQF
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 255d
Cleared Nov 14, 2019
LongBow Ti
K190721 · MAX
Life Spine, Inc.
Orthopedic · 239d
Cleared Nov 14, 2019
HeraBEAT™ US
K191110 · KNG
Heramed, Ltd.
Obstetrics & Gynecology · 202d
Cleared Nov 14, 2019
E-100 Electrosurgical Generator, SynchroSeal
K191280 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 185d
Cleared Nov 14, 2019
ST Internal Implant System
K192347 · DZE
Megagen Implant Co., Ltd.
Dental · 77d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
K192355 · JWY
Beckman Coulter, Inc.
Microbiology · 77d
Cleared Nov 14, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Nov 14, 2019
Brainlab Compatible K2M Navigation Instruments
K192911 · OLO
K2m, Inc.
Orthopedic · 30d
Cleared Nov 13, 2019
EchoGo Core
K191171 · QIH
Ultromics, Ltd.
Radiology · 196d
Cleared Nov 13, 2019
AEON-C Stand Alone System
K191477 · OVE
Huvexel Co. , Ltd.
Orthopedic · 162d
Cleared Nov 13, 2019
Infrared Thermometer Model MD-H30
K191570 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 153d
Cleared Nov 13, 2019
Piper GO-IO Intraosseous Infusion System
K191976 · FMI
Piper Access, LLC
General Hospital · 112d
Cleared Nov 13, 2019
AMICUS Separator System
K192150 · LKN
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Nov 13, 2019
Nox Sleep System
K192469 · OLZ
Nox Medical
Neurology · 65d
Cleared Nov 13, 2019
NuVasive CoRoent Small Interlock System
K192582 · OVE
Nu Vasive, Incorporated
Orthopedic · 55d
Cleared Nov 13, 2019
GMA 2.0 Pedicle Screw System
K192915 · NKB
Grafton Medical Alliance
Orthopedic · 29d
Cleared Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
K190799 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 229d
Cleared Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
K191161 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 195d
Cleared Nov 12, 2019
ARIX Wrist System
K191972 · HRS
Jeil Medical Corporation
Orthopedic · 111d
Cleared Nov 12, 2019
Clear21
K192202 · NJM
World Class Technology Corporation
Dental · 90d
Cleared Nov 12, 2019
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · DSP
Arrow International, Teleflex
Cardiovascular · 85d
Cleared Nov 12, 2019
LaseMD LEO Laser System
K192331 · GEX
Lutronic Global
General & Plastic Surgery · 77d
Cleared Nov 12, 2019
FDR D-EVO III flat panel detector system
K192932 · MQB
Fujifilm Corporation
Radiology · 26d