BEUDAMED
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    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000215, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Spinal and Biologics Business, Memphis, TN (this guide was originally a portion of the Satellite Spinal System Primary User Group Reference Guide a 8 1/2 by 11 inch plastic binder)

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000210, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000213, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 800021, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000211, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000213, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000209, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000214, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000215, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000216, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000212, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·February 28, 2018

    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·February 28, 2018