BEUDAMED
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    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 7, 2012

    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 9, 2018

    StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 9, 2018

    StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 9, 2018