BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    CHECK-MM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·December 21, 2012

    RSP SHOULDER INSTRUMENT

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HWX·October 20, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    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