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

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    COMPLEMENT C3 NEPHELOMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VENTILATOR SET - CODE 2C7109

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 25, 2014

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 2, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 22, 2010

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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