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

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    DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Kinetic Dynamic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837004903·

    TRAY, URETHRAL CATHETERIZATION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Elecsys Anti-HAV IgM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAPSUREFIX NOVUS

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

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 31, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 17, 2010

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    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