351 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pentalumen TD Thermodilution Catheter, Sterile
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DYG·November 19, 2003
Right Heart Catheter Product Line: Catalog Number 601258----WP604P Wedge Press Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.
FDA Recall
Terminated
·Arrow International Inc·Product code DYG·March 4, 2013
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·December 21, 2018
Right Heart Catheter Product Line: Catalog Number 604057---------------T147 A427D1014KANI
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 601272------WP1106 Wedge Press Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604025------------T046-02 0426D1009I RMM.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604264-------------427D1006I Round Molded Manifold.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 601285-----WP11055 Wedge Press Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·December 21, 2018
Right Heart Catheter Product Line: Catalog Number 604239-------------426D1009I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 608054------------827D1006I 4P BBM RMM Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·December 21, 2018
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012