BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    UNI-FAST CREATINE KINASE TEST (CK)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709433·GC Initial™ PC Pellets Transl. TY, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720291·GC Initial™ PC Pellets Transl. TY, 5pcs. X 2

    PHENIX VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EnsoETM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDURANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 13, 2014

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 8, 2010

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·December 11, 2012

    Plastic Kit, part number CMP1084(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017