BEUDAMED
    16 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

    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-2117.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

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

    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-2110. May be included with the Olympus OER-ELITE.

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

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Inc.·March 5, 2014

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

    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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

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

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Enforcement
    Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025