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

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    CHOLESTEROL (RATE) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SALUMEDICA NERVE CUFF

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·May 6, 2014

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 18, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 8, 2013

    PIPELINE FLEX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 30, 2020

    CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021