BEUDAMED
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    MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    OT ULTRA METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 3, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 27, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 3, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 6, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 1, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 16, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 19, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 22, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 30, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 2, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 12, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 21, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 24, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 9, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 9, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 4, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 25, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 5, 2012