BEUDAMED
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    BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVIA® Chemistry µALB Microalbumin Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414517643·Microalbumin - ADVIA Chem. - RGT - 4x105/4x130...

    STERICHEK TOTAL CHLORINE REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 20, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 28, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 12, 2018

    GENESIS PULSE GENERATOR, 8-CHANNEL

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 6, 2011

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    EXPORT XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code DXE·May 22, 2008

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD.·Product code FGE·April 11, 2011

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 5, 2012

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    ZILVER 635 SELF EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2014

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 12, 2017

    ZILVER 635 BILIARY SELF EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 13, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 10, 2010