BEUDAMED
    34 results · 22ms · Sources: EU EUDAMED, US FDA

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    PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MADIGAN ARMY TACOMA WA 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 7, 2009

    UNIV OF VA CHARLOTTESVILLE VA1

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·December 28, 2010

    HCSG MIDWEST REG LEXINGTON KY1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP USA ITALIA·Product code DTZ·November 27, 2012

    PENROSE HSP CO SPRINGS CO 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·April 4, 2007

    UNIV OF VA CHARLOTTESVILLE VA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·April 20, 2011

    WV UNIV HSP MORGANTOWN WV 1

    FDA Adverse Event
    Other ·SORIN GROUP USA·Product code DTZ·November 10, 2011

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 8, 2013

    UNIV OF CHARLOTTESVILLE VA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·April 21, 2011

    UNIV OF VA CHARLOTTESVILLE VA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·March 1, 2010

    UNIV OF VA CHARLOTTESVILLE VA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·March 29, 2010

    UNIV OF VA CHARLOTTESVILLE VA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·April 15, 2011

    DIDECO COMPACT FLOW EVO OXYGENATOR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 24, 2013

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

    SC ASHLAND KY 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code DTZ·February 8, 2012

    ST JOES/CLARES MARSHFIELD WI1

    FDA Adverse Event
    Death ·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010

    MAINE MED PORTLAND ME 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWF·June 6, 2012

    HCA MW DIV KANSAS CITY MO 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·June 8, 2012

    PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 1, 2018