BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Disposable guides KDNG00

    FDA 510(k)
    FDA Class 2 ·Radiology

    STAINLESS STEEL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    USHIFU STEPPER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 20, 2013

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC·Product code CGA·July 1, 2011

    IMPACTOR F/PFNA BLADE

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWA·October 17, 2014

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019