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    NAVISTAR THERMOCOOL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAD·December 1, 2025

    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code lZE·July 25, 2014

    Isometer

    FDA classification
    FDA Class 1 ·Isometer

    Shandong Lee Med Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·9 Basic UDI-DIs·35 Devices·1 Importer·TÜV Rheinland LGA Products GmbH

    Hangzhou Lee Kai Technology Co., Ltd

    Manufacturer
    🇨🇳 China

    Huai An Hua Lve Electronics Co.,Ltd.

    Manufacturer
    🇨🇳 China

    Gan & Lee Pharmaceuticals Shandong Co., LTD

    Manufacturer
    🇨🇳 China

    Lee Medical

    FDA registration
    Lee Medical·2 products·🇺🇸 United States

    LTE TIBBİ ALETLER SANAYİ TİCARET VE LİMİTED ŞİRKETİ

    Manufacturer
    🇹🇷 Türkiye

    DIVERSITY CORPORATION FZE

    FDA registration
    DIVERSITY CORPORATION FZE·20 products·🇦🇪 United Arab Emirates

    LEE LABORATORIES, INC.

    FDA registration
    LEE LABORATORIES, INC.·13 products·🇺🇸 United States

    SURGYMED TRADING FZE

    FDA registration
    SURGYMED TRADING FZE·3 products·🇦🇪 United Arab Emirates

    FUZE

    FDA UDI
    VILEX LLC·00841731120717·FUZE End Cap Ti, Hexalobe

    Perfect Ophthalmic Instruments FZE

    FDA registration
    Perfect Ophthalmic Instruments FZE·79 products·🇦🇪 United Arab Emirates

    LEE SURGICAL INNOVATIONS, INC.

    FDA registration
    LEE SURGICAL INNOVATIONS, INC.·1 product·🇺🇸 United States

    MALLYA D CZE

    Device
    EU MDR · Eu Md Class 1 ·BIOCORP PRODUCTION·On the market

    Eze-Sit® Valvulotome

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    ARTICUL/EZE S-ROM

    FDA UDI
    DEPUY INTERNATIONAL LTD·10603295220756·SROM ARTICULEZE NECK TRIAL 36+12LAT

    ARTICUL/EZE S-ROM

    FDA UDI
    DEPUY INTERNATIONAL LTD·10603295220701·SROM ARTICULEZE NECK TRIAL 36+4LAT

    ARTICUL/EZE S-ROM

    FDA UDI
    DEPUY INTERNATIONAL LTD·10603295220725·SROM ARTICULEZE NECK TRIAL 36+21CR