BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    CASS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODEL 493-01 PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SETMA FHT, MODEL ST 8130

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    FDA Adverse Event
    Malfunction ·VOLCANO S.R.L.·Product code OBJ·February 19, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 3, 2010

    XCALIBER BONE SCREW STERILE L 260/60MM THREAD

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code JDW·December 27, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020