BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    DI ISOLATION GOWN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    25-Hydroxy Vitamin Ds EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Zeta Cranial Navigation System (ZNS131-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·February 4, 2013

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·December 22, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 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