BEUDAMED
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    BEAMER ARGON PROBE

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

    Harvard Temp C&B Pro A3,5

    FDA UDI
    Harvard Dental International GmbH·EHAR70816441·Temporary crown and bridge material 4:1

    BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERF (OMMAYA STYLE) RESERVOIRS

    FDA 510(k)
    FDA Class 2 ·Neurology

    STERRAD 50 STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·April 29, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 11, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 23, 2008

    Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    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