BEUDAMED
    16 results · 18ms · 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

    Luer-Split MAJ-2092

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

    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

    CYBERDYNE Inc.

    Manufacturer
    🇯🇵 Japan·TÜV Rheinland LGA Products GmbH

    Echo Electricity Co., Ltd

    Manufacturer
    🇯🇵 Japan·SGS Belgium NV

    OLYMPUS MEDICAL SYSTEMS CORP.

    Manufacturer
    🇯🇵 Japan·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    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

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    DZ 2081569-1

    Certificate
    MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH

    DZ 2158445-1

    Certificate
    MDR QA·OLYMPUS MEDICAL SYSTEMS CORP.·TÜV Rheinland LGA Products GmbH

    JP24/00000218

    Certificate
    MDR QA·Echo Electricity Co., Ltd·SGS Belgium NV