17 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
Dalbo®-Z
FDA UDI
Cendres+Métaux SA·07640166513766·Dalbo®-Z OE
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
FDA 510(k)
FDA Class 2
·Hematology
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 21, 2017
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 4, 2011
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 8, 2013
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
IPC® HANDPIECE - STYLUS TOUCH®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018