BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    BONE CUTTING FORCEPS, DOUBLE-ACTION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077304·13MM PADDLE DISTRACTOR

    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYSTEMIC LUPUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 22, 2010

    MARYLAND BIPOLAR FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 29, 2012

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021

    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