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

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    IVALON OPHTHALMIC SPONGE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NA

    FDA UDI
    Zimmer, Inc.·00889024105119·

    NA

    FDA UDI
    Zimmer, Inc.·00889024105102·

    QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)

    FDA 510(k)
    FDA Class 2 ·Hematology

    NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157439·

    UNO

    FDA Adverse Event
    Malfunction ·LIKO AB·Product code FSA·December 17, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013

    HERO GRAFT

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·July 21, 2014

    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