BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIOELECTRICAL IMPEDANCE ANALYZER #101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GROMAN PREPMASTER

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 23, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 13, 2012

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·August 10, 2007

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·October 24, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·October 24, 2018