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

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    COOL 'N HEAT MACHINE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JKH Stimulator Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014

    SCULPTURA

    FDA Adverse Event
    Injury ·Product code LMH·November 2, 2010

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 21, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014