BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    RESPIRATORY CIRCUIT ADAPTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DRYSTAR 5500

    FDA 510(k)
    FDA Class 2 ·Radiology

    Velacur

    FDA 510(k)
    FDA Class 2 ·Radiology

    STANDARD STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 27, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2012

    INTERNAL PADDLES ADAPTER CABLE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·August 28, 2010

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·September 21, 2022

    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