BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    MAC-MULTI-ADJUSTABLE CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INFINITY PLUS ELECTROTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Wrist Hemiarthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 30, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·November 21, 2012

    UNK CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HSA·August 31, 2010

    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