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

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

    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Enforcement
    Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025

    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08

    FDA Enforcement
    Class II ·Ongoing·Medivance Inc.·August 7, 2024