BEUDAMED
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    Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 14, 2024

    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 30, 2023

    Olympus OER-Elite

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Pro

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Mini

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 26, 2016

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·February 23, 2022

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026