BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MAMM-AIRE

    FDA 510(k)
    FDA Class 1 ·Radiology

    MODEL ZY PACEMAKER LEAD-VARIOUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COATEST ANTIPLASMIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    DURALOC 300 SERIES 56MM OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 10, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 11, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024