BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Hematology

    COMPRESSIBLE LIMB SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·January 9, 2013

    CROSSVENT

    FDA Adverse Event
    Malfunction ·BIO-MED DEVICES, INC.·Product code CBK·November 18, 2010

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015