BEUDAMED
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    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONIC INC.·Product code FEB·November 27, 2013

    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC·Product code KOG·February 18, 2014

    CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC·Product code KOG·December 21, 2012

    SYSTEM 83 PLUS

    FDA Adverse Event
    Death ·CUSTOM ULTRASONICS INC.·Product code FEB·March 24, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    Other ·CUSTOM ULTRASONICS·Product code KOG·November 20, 2012

    CUSTOM ULTRASONICS, INC.

    FDA Adverse Event
    Other ·CUSTOM ULTRASONICS INC.·Product code FLG·September 18, 2008

    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FLG·June 28, 2013

    SYSTEM 83 PLUS

    FDA Adverse Event
    Injury ·CUSTOM ULTRASONICS INC.·Product code KOG·October 11, 2013

    SYSTEM 83 PLUS

    FDA Adverse Event
    Injury ·CUSTOM ULTRASONICS INC.·Product code KOG·October 11, 2013

    SYSTEM 83 PLUS9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FEB·August 20, 2015

    SYSTEM 83 PLUS

    FDA Adverse Event
    CUSTOM ULTRASONICS INC.·Product code FEB·April 6, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    CUSTOM ULTRASONICS INC.·Product code FEB·April 4, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    CUSTOM ULTRASONICS INC.·Product code FEB·April 6, 2016

    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FLG·September 7, 2013

    SYSTEM 83 PLUS

    FDA Adverse Event
    Death ·CUSTON ULTRASONICS INC.·Product code FEB·April 6, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    Death ·CUSTOM ULTRASONICS INC.·Product code FEB·April 15, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    Death ·CUSTOM ULTRASONICS INC.·Product code FEB·April 6, 2016

    SYSTEM 83 PLUS

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FEB·December 30, 2015

    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FEB·August 10, 2015

    SYSTEM 83 PLUS 9

    FDA Adverse Event
    Malfunction ·CUSTOM ULTRASONICS INC.·Product code FEB·August 10, 2015