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

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    ELECTROCARDIOGRAPH CONTINUOUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUADROSTAR 532

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAPSUREFIX

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

    LIFEVEST WCD 4000 SYSTEM

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

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 22, 2015

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 24, 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