BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    PINNACLE 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMERICA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IL TEST IMMUNOGLOBULIN M (IGM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 30, 2014

    UNKNOWN DEPUY PFC SZ 3 CRUCIFORM TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 23, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021