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

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 23, 2024

    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

    FDA Enforcement
    Class II ·Ongoing·mo-Vis BVBA·January 17, 2024

    VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·October 8, 2025

    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 30, 2022

    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020