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

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    SHEATH/DILATORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709860·GC Initial™ IQ/Correction Powder B2-Zr, 5g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228727241·GC Initial™ IQ/Correction Powder B2-Zr, 5g

    XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CXI SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·June 13, 2014

    ACTICON NEOSPHINCTER

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·October 11, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012