11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Intracept Intraosseous Nerve Ablation System
FDA 510(k)
FDA Class 2
·Neurology
BD Difco™ Neisseria Meningitidis Antiserum Group A
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902222811·BD Difco™ Neisseria Meningitidis Antiserum Group A
HEALIX TRANSTEND
FDA UDI
DEPUY MITEK, LLC·10886705020331·HEALIX TRANSTEND Drill Bit 2.2mm
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 12, 2019
PADNET 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
FDA 510(k)
FDA Class 2
·Cardiovascular
DEDO LASER MICRO LARYNGOSCOPE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·November 23, 2015
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 24, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018