BEUDAMED
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    ANALYTICAL REVIEW STATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978084824·INSTRUMENT 955-519 MED GUIDEWIRE

    ARx SAI

    FDA UDI
    Life Spine, Inc.·00190837194369·

    MONTROSE DRESSING APPLICATORS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SONOTONE BEHIND THE EAR MODEL ST 53A

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DTB·February 11, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2014