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

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    CRIT-LINE HEMATOCRIT ALERT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Contour Next USB Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CR TIBIAL INSERT TRIAL #4 - 9MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·February 8, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 22, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020