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

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    SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CMA CEREBRAL TISSUE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014

    TRILOGY 202

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 31, 2012

    LIFEGUARD

    FDA Adverse Event
    Malfunction ·CHURCHILL MEDICAL SYSTEMS INC·Product code FMI·July 1, 2010

    3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·October 17, 2012