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

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    DADE(R) CK-MB IMMUNOASSAY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

    FDA 510(k)
    FDA Unclassified ·Unknown

    LENSAR Laser System - fs 3D (LLS-fs 3D)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 22, 2010

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 20, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·December 20, 2012

    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·February 19, 2020