BEUDAMED
    2 results · 56ms · 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: Terminated ×

    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

    FDA Enforcement
    Class I ·Terminated·Eight Medical International BV·August 4, 2021

    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

    FDA Recall
    Terminated ·Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands·Product code LGZ·June 4, 2021