37 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·October 3, 2018
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 16, 2014
Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·April 17, 2008
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·May 1, 2004
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 12, 2003
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·May 1, 2004
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·August 28, 2018
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 19, 2005
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·November 1, 2005
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·February 1, 2005
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·June 3, 2015
Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 21, 2013