BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALPHA PUSH KART

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OPTIMUS NEURO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHES (USA) LCP CURVED PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 30, 2014

    FRESENIUS DIALYZER-OGDEN

    FDA Adverse Event
    Injury ·OGDEN MANUFACTURING·Product code KDI·November 14, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 23, 2010

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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