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

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    CATHETER, THERMAL DILUTION, OPEN CHEST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MASKMEDIC CONCEPT NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RenovoCath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 26, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 17, 2013

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 8, 2015

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·October 3, 2012