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    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

    FDA Recall
    Terminated ·Kowa Optimed Inc·Product code NFJ·November 3, 2020

    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

    FDA Enforcement
    Class II ·Terminated·Kowa Optimed Inc·December 23, 2020

    POLYOFTALMICA NEW S.R.L.

    Importer
    🇮🇹 Italy·9 Manufacturers

    bon Optic Vertriebsgesellshaft mbH

    Importer
    🇩🇪 Germany·12 Manufacturers

    FAX INTERNATIONAL OPHTALMICS INSTRUMENTS

    Importer
    🇫🇷 France·10 Manufacturers

    UAB Kavita

    Importer
    🇱🇹 Lithuania·18 Manufacturers

    Prolinx GmbH

    Authorized representative
    🇩🇪 Germany·97 Manufacturers·1780 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices