BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

    FDA Enforcement
    Class II ·Ongoing·Covidien·May 8, 2024

    PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    APD Drain Manifold

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·June 8, 2022

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    FDA Enforcement
    Class III ·Ongoing·R & D Systems, Inc.·July 27, 2022

    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Bivona Aire-Cuf Endotracheal Tube

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021