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

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    HELENA FACTOR VIII DEFICIENT SUB. PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111079·SILICONE MAT FOR K 9-2330

    TRACKER Kyphoplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEAK EXPIRATORY FLOW METER, KN-9710

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·May 6, 2014

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·October 12, 2012

    ENDURANT IIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·May 22, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020