BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    URESIL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COMPAC(TM) DIODE LASERS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·January 18, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    AUTOPULSE® LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·August 4, 2014

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015