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

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    URIC ACID REAGNET SET (TRINDER)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414553146·ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests

    CATAMARAN™ SI Joint Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    The Luco Hybrid OSA Appliance

    FDA 510(k)
    FDA Unclassified ·Unknown

    VIVA XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    EVA BAG-500ML

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SAO PAULO·Product code BTC·October 7, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 5, 2012

    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