BEUDAMED
    9 results · 31ms · Sources: EU EUDAMED, US FDA

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    MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·June 27, 2019

    ER920W EVENT RECORDER

    FDA Adverse Event
    Other ·BRAEMAR, INC.·Product code DRG·May 19, 2011

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Recall
    Terminated ·BRAEMAR, INC.·Product code DRG·May 2, 2011

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Enforcement
    Class II ·Terminated·BRAEMAR, INC.·July 10, 2013

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·August 29, 2019

    ER920W EVENT RECORDER

    FDA Adverse Event
    Malfunction ·BRAEMAR MANUFACTURING, INC.·Product code DRG·January 5, 2015

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Recall
    Terminated ·BRAEMAR, INC.·Product code DRG·February 24, 2012

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Enforcement
    Class II ·Terminated·BRAEMAR, INC.·July 10, 2013

    MCOT PATCH

    FDA Adverse Event
    Injury ·BIO TELEMETRY, INC. / BRAEMAR MANUFACTURING, LLC·Product code DRX·September 23, 2020