BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 8, 2015

    Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·July 25, 2018

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 12, 2014

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·July 18, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 7, 2018

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Edward Lifesciences, Llc·September 23, 2015

    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·May 22, 2013

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

    Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 21, 2013

    Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 21, 2013