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

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    PTT AUTOMATE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G7 Dual Mobility System, Active Articulation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 2, 2012

    Vanguard XP Tibial Tray 75 mm Item # 195251

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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