BEUDAMED
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    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.

    FDA Recall
    Terminated ·Baxter Healthcare Corp·Product code FRN·March 2, 2015

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DXC·May 5, 2015

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·May 5, 2015

    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    FDA Recall
    Terminated ·Vilex In Tennessee Inc·Product code HSB·April 22, 2015

    Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    FDA Recall
    Terminated ·Vilex In Tennessee Inc·Product code HSB·April 22, 2015

    Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.

    FDA Recall
    Terminated ·Cook Inc.·Product code GBZ·May 28, 2015

    Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    FDA Recall
    Terminated ·Vilex In Tennessee Inc·Product code HSB·April 22, 2015

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    FDA Recall
    Terminated ·Cook Inc.·Product code DYB·May 28, 2015

    cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·March 15, 2016