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

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    WRAPPERS, SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FIBER OPTICS HIGH SPEED HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    PROGENIX DBM PUTTY AND PASTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·December 5, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·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