BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    ARGYLE SILICONE TRACHESTOMY TUBE W/LOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO HERMES O.R. CONTROL CENTER

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

    HIVOX SELF ADHESIVE ELECTRODE GEL PADS

    FDA 510(k)
    FDA Class 2 ·Neurology

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 27, 2014

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 9, 2012

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·January 4, 2008

    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