BEUDAMED
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    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023

    LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023

    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 19, 2025

    NIKON-ESSILOR CO., LTD.

    Manufacturer
    🇯🇵 Japan

    ASHITAKA FACTORY OF TERUMO CORP.

    FDA registration
    ASHITAKA FACTORY OF TERUMO CORP.·20 products·🇯🇵 Japan

    Tanita Corporation of Akita, Ltd

    FDA registration
    Tanita Corporation of Akita, Ltd·5 products·🇯🇵 Japan

    KOFU FACTORY OF TERUMO CORP.

    FDA registration
    KOFU FACTORY OF TERUMO CORP.·6 products·🇯🇵 Japan

    ME CENTER OF TERUMO CORP.

    FDA registration
    ME CENTER OF TERUMO CORP.·1 product·🇯🇵 Japan

    ME Center (Nagaizumi) of Terumo Corp

    FDA registration
    ME Center (Nagaizumi) of Terumo Corp·1 product·🇯🇵 Japan

    Asahi Lite Optical Co., Ltd.

    Manufacturer
    🇯🇵 Japan

    Toray Industries, Inc.

    Manufacturer
    🇯🇵 Japan·2 Importers

    Toray Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·1 Importer

    Tokuyama Dental Corporation

    Manufacturer
    🇯🇵 Japan·1 Importer

    Kaigen Pharma Co., Ltd.

    Manufacturer
    🇯🇵 Japan

    Matsunaga Manufactory Co.,ltd.

    Manufacturer
    🇯🇵 Japan

    Sun Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·41 Basic UDI-DIs·55 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    OPHTECS Corporation

    Manufacturer
    🇯🇵 Japan·8 Basic UDI-DIs·20 Devices·1 Importer

    TSK Laboratory International Japan KK

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device

    HOYA Technosurgical Corporation

    Manufacturer
    🇯🇵 Japan

    CITIZEN SYSTEMS JAPAN CO., LTD.

    Manufacturer
    🇯🇵 Japan·1 Importer