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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023