BEUDAMED
    34 results · 28ms · Sources: EU EUDAMED, US FDA

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    XLTEK EMU40EX EEG Headbox

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROPACE BURR HOLE COVER MODEL 8110

    FDA 510(k)
    FDA Class 2 ·Neurology

    PENUMBRA SYSTEM MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    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
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 7, 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

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013

    CORAIL2 LAT COXA VARA SIZE 14

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWA·July 8, 2011

    MAQUET

    FDA Adverse Event
    MAQUET GMBH AND CO. KG·Product code FQO·March 14, 2008

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code JJE·June 14, 2018

    Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Enforcement
    Class I ·Ongoing·Allergan PLC·September 18, 2019

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·February 14, 2017

    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·April 5, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

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

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018