BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    CASF DRILL GUIDE DG 170

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    Mini TENS Therapy Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·April 4, 2014

    S8 ELITE - AMERICAS

    FDA Adverse Event
    Malfunction ·RESMED LTD.·Product code BZD·October 22, 2010

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·December 21, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021