BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    1.2 MICRON FILTER WITH IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SRS-200 RADIOSURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TOTAL CARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 20, 2014

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 10, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014