BEUDAMED
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    Roadrunner Extra Support Wire Guide

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·January 19, 2021

    WINGEATER V2

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

    AEQUALIS REVERSED ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPILEPSY 64 GRID

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code GYC·October 20, 2004

    HARMONIC ACE CURVED SHEARS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·June 3, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 15, 2011

    NAVILYST / VAXCEL

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code LJS·September 19, 2008

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 20, 2023

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 24, 2024

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 4, 2022

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021