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

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    COLLI-MATETM MODEL NO. B800

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDTRONIC MODEL 6912

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERMA HB-METER MODEL 303N

    FDA 510(k)
    FDA Class 2 ·Hematology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 24, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 19, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·December 15, 2012

    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