BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    FIX. & LENS FOR. #'S 3510,3512,3248,3795

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 10, 2021

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 24, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·January 1, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·November 5, 2010

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012