BEUDAMED
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    HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLIDESHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 19, 2014

    MINIATURE PIN AND LIGATURE CUTTER

    FDA Adverse Event
    Malfunction ·GAC INTERNATIONAL·Product code EJB·October 22, 2010

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code MCX·December 20, 2012

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022

    GLIDESHEATH

    FDA Adverse Event
    Death ·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 2, 2021

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 18, 2022

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·October 9, 2018

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 3, 2020