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

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    VAX-T PELVIC TRACTION BELT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CROWN & BRIDGE RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    VIROGEN RUBELLA SLIDE TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PLUM A+ UK WITH 3PIN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·November 9, 2010

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·December 27, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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