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

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    URIC ACID REAGENT SET (COLORIMETRIC)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482233·PLATE 6860142 42.5MM ANTERIOR CERVICAL

    MINERAL OIL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN ABILITY PLUS

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

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·November 30, 2012

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    FDA Adverse Event
    Malfunction ·KEYSTONE DENTAL·Product code NHA·September 21, 2010

    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