48 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Arrow International Inc·April 10, 2013
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 604000------417D1006I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
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 604028------------T047(90) 427D1022I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604165-------------T047-04 0427D1022I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604037------T047-02 0427D10061.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 604103-------------T047(97) 427D4036I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
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
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 604315-------------406-1H-018 426D1009I18PP.
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
Right Heart Catheter Product Line: Catalog Number 601293------------WP1107S Monitory Wedge Press.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 608055-------------827D1006I 4P BBM RMM Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Cath.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005