17 results · 26ms · Sources: EU EUDAMED, 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