BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SLEEP MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    GE DATEX-OHMEDA AVANCE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    One Touch

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 27, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 13, 2011

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 5, 2014

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015