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    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

    Eight Medical International B.V.

    Manufacturer
    🇳🇱 Netherlands

    Recirculator

    FDA UDI
    Eight Medical International B.V.·08719992086009·The Recirculator 8.0 is comprised of two comp...

    Lavage Procedure Kit

    FDA UDI
    Eight Medical International B.V.·08719992086016·The disposable single-use Lavage Procedure Kit ...

    TRIDENT 0 DEG INSERT 36MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 18, 2019

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices