BEUDAMED
    4 results · 13ms · Sources: EU EUDAMED, US FDA

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    SQ40S Blood Transfusion Filter

    FDA Enforcement
    Class II ·Ongoing·GVS TM, Inc·January 28, 2026

    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

    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