BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Japan ×

    Water Container (MAJ-901); Water Container (MAJ-902)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Distal Cover MAJ-2315 (MAJ-2315)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TWiNY Opaque OA2 2.0ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    TWiNY Opaque OA1 2.0ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luer-Split MAJ-2092

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    iGOS Universal OA2 4g (2ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·2 countries

    Luna-Wing Opaque OA2 2.3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luna-Wing Opaque OA1 2.3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·9 countries

    Luna-Wing Opaque OA0 2.3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    AUXILIARY WATER TUBE MAJ-855

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single-Use Biopsy Valve (MAJ-1555)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TMR-ZFill10. Universal OA2 3.8g (2ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·32 countries

    iGOS Flow OA2 2.6 g (1.5 ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·2 countries

    TWiNY Opaque Red Plus OA2 R 2.0ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    iGOS Low Flow OA2 2.6 g (1.5 ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·2 countries

    TMR-ZFill10. Flow OA2 2.6 g (1.5 ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·32 countries

    TMR-ZFill10. Low Flow OA2 2.6 g (1.5 ml)

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·32 countries

    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology