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

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    END TIDAL CO2 SAMPLING CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CALCIPULPE

    FDA 510(k)
    FDA Class 2 ·Dental

    ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·October 26, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012