BEUDAMED
    15 results · 49ms · Sources: EU EUDAMED, US FDA

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    ECG ELECTRODES

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·May 5, 2000

    HI RES ELECTRODE

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·June 17, 2000

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·December 8, 2010

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    CAMBRIDGE HEART, INC.·Product code DRX·September 21, 2011

    HI RES ELECTRODES

    FDA Adverse Event
    Other ·CAMBRIDGE HEART, INC.·Product code JOS·July 29, 1998

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·December 31, 2007

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·September 30, 2009

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code DRX·September 10, 2007

    MICRO-V ALTERNANS SENSORS

    FDA Adverse Event
    Other ·CAMBRIDGE HEART, INC.·Product code DRX·May 26, 2011

    HI-RES ELECTRODE

    FDA Adverse Event
    Other ·CAMBRIDGE HEART INC.·Product code DRX·December 9, 1997

    MICRO V ELECTRODE

    FDA Adverse Event
    Injury ·CAMBRIDGE HEART, INC.·Product code JOS·September 7, 2006

    CH 2000 STRESS TEST SYSTEM

    FDA Adverse Event
    Malfunction ·CAMBRIDGE HEART, INC.·Product code DPS·March 17, 1999

    The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

    FDA Recall
    Terminated ·Cambridge Heart, Inc.·Product code DRX·April 29, 2010

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices