BEUDAMED
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    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00887661196859·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00037435003887·

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850022960352·Level 3 Disposable Surgical Gown, XXLarge, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850032920476·Level 3 Disposable Surgical Gown, 5XLarge, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850022960321·Level 3 Disposable Surgical Gown, Medium, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850022960338·Level 3 Disposable Surgical gown, Large, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850022960369·Level 3 Disposable Surgical Gown, Small

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850032920469·Level 3 Disposable Surgical Gown, 4XLarge, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850022960345·Level 3 Disposable Surgical Gown, Xlarge, Blue

    Texas Medical Technology

    FDA UDI
    Texas Medical Technology Inc·00850032920452·Level 3 Disposable Surgical Gown, 3XL, Blue

    Disc-FX® Guidewire

    FDA UDI
    ELLIQUENCE, LLC·00846338010911·

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·June 15, 2016

    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

    FDA Enforcement
    Class II ·Ongoing·Texas Medical Technology Inc.·November 23, 2022

    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

    FDA Recall
    Open, Classified ·Texas Medical Technology Inc.·Product code FYA·September 1, 2022

    EVIS LUCERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·March 15, 2022

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·March 15, 2022

    BIS

    FDA Adverse Event
    Malfunction ·ASPECT MEDICAL·Product code GWS·November 29, 2017

    NOHON KOHDEN, EEG

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN AMERICA, INC.·Product code GWS·December 23, 1996

    HT TURNTRAC GUIDE WIRE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·July 31, 2020

    HT TURNTRAC

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·July 31, 2020