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

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    ACUSCREEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYMBIQ SCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 7, 2014

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code LWJ·June 6, 2015

    DRIVER RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MAF·August 26, 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