BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Completed ×

    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

    FDA Enforcement
    Class II ·Completed·Fresenius Kabi USA, LLC·March 20, 2024

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

    FDA Recall
    Completed ·Fresenius Kabi USA, LLC·Product code FRN·May 10, 2023