BEUDAMED
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    JAPAN OPTICAL CO.,LTD.

    Manufacturer
    🇯🇵 Japan

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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

    MASAHIRO MARUYAMA Inc.

    Manufacturer
    🇯🇵 Japan

    NIDEK.CO.Ltd.,

    Manufacturer
    🇯🇵 Japan·27 Basic UDI-DIs·61 Devices·10 Importers

    NIKON-ESSILOR CO., LTD.

    Manufacturer
    🇯🇵 Japan

    OKAMOTO INDUSTRIES, INC. Ibaraki Plant

    Manufacturer
    🇯🇵 Japan·2 Importers

    Menicon Co., Ltd.

    Manufacturer
    🇯🇵 Japan·4 Importers

    NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY

    Manufacturer
    🇯🇵 Japan·1 Importer

    EYEVAN Inc.

    Manufacturer
    🇯🇵 Japan·30 Basic UDI-DIs·1910 Devices·1 Importer

    MATSUDA EYEWEAR JAPAN LLC

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·575 Devices·1 Importer

    Sagami Rubber Industries Co., Ltd.

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·26 Devices

    GE Healthcare Japan Corporation

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·8 Devices

    CYBERDYNE Inc.

    Manufacturer
    🇯🇵 Japan·TÜV Rheinland LGA Products GmbH

    iLAND solutions Co. Ltd.

    Manufacturer
    🇯🇵 Japan

    Hitachi High-Tech Corporation

    Manufacturer
    🇯🇵 Japan·118 Basic UDI-DIs·288 Devices·1 Importer