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

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    SURGICAL RETRACTORS

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

    BIPAP AUTOSV

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARIETTA 50

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIPAP AUTOSV ADV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 10, 2022

    GRANUFLO

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

    KINETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 22, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012