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

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    COLON IRRIGATION UNIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 30, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012

    TERUMO CDI 100 MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·September 17, 2010

    VERSYS FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER, TURPEAUX INDUSTRIAL PARK·Product code JDI·March 31, 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