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

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    EDL ONE-STAGE PROTHROMBIN TIME REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    DreaMed Advisor Pro

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RADIA STEERABLE DIAGNOSTIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN OTW

    FDA Adverse Event
    Death ·MPRI·Product code LWP·June 24, 2014

    SIGMA MODEL SPECTRUM

    FDA Adverse Event
    Malfunction ·SIGMA LLC·Product code FRN·October 22, 2010

    QUADROX-ID

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 21, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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