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

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    BEACH EXPLORER NO. 23T.G.

    FDA 510(k)
    FDA Class 1 ·Dental

    INVASIVE ACCESSORIES AND INSTRUMENTS

    FDA UDI
    RHEIN 83 SRL·D821780·REUSABLE and STERILIZABLE device. Bur with spec...

    ADVANTAGE SIM 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    OXY CUSTOM TRAY RESIN

    FDA 510(k)
    FDA Class 1 ·Dental

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·May 20, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 26, 2010

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 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