BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    BREAST LESION LOCALIZATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PERRY(R) CUT-RESISTANT GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PLURA-GARD CHEST DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 6, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·July 18, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017