BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    BREAST CARE KIT

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    CG-6108 ARRHYTHMIA ECG EVENT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIDAS B.R.A.H.M.S. PCT (PCT)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 21, 2014

    M2A-MAGNUM TAPER ADAPTER TYPE I TAPER 52-60MM HEAD SIZE -6MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 26, 2012

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 14, 2010

    Calix T PEEK Lumbar System, TLIF Trial

    FDA Enforcement
    Class II ·Terminated·X Spine Systems Inc·October 26, 2016