BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    INHAMATIC 33

    FDA 510(k)
    FDA Class 1 ·Radiology

    BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·April 30, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012

    WAVESENSE JAZZ GLUCOSE METER

    FDA Adverse Event
    Malfunction ·AGAMATRIX, INC·Product code NBW·July 24, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025