BEUDAMED
    6 results · 20ms · Sources: EU EUDAMED, US FDA

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    KET-1 Blood Ketone Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SYNTHETIC, POWDER-FREE NITRILE EXAMINATION

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 21, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code JOR·July 11, 2011