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

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    NEBULIZER CHRONOLOG & INTERPRETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    32HQ713D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·November 7, 2012

    UNK

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 25, 2010

    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·April 20, 2016