BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Q-Pad Test System

    FDA 510(k)
    FDA Class 2 ·Hematology

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    MODEL 2100 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SuRgical Planner (SRP) BrainStorm

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    EXPANSION KIT: SILVER SOAKER CATHETER 2.5 INCH

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code BSO·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022