BEUDAMED
    3 results · 26ms · Sources: EU EUDAMED, US FDA

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    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    FDA Enforcement
    Class II ·Ongoing·Oxoid Limited·February 12, 2025

    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

    FDA Enforcement
    Class II ·Ongoing·Oxoid Australia Pty Limited·April 8, 2026

    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·July 23, 2014