358 results
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Sources: EU EUDAMED, US FDA
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EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014
Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. 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 Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTS·February 5, 2008
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTM·July 26, 2013
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). 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 (4 inch diameter Roller Pump; Model 801040). 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 Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code MNJ·June 4, 2013
Toshiba Aquilion ONE CT SystemTSX-301 A/2D
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·February 3, 2009
Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571). 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 (6 inch diameter Roller Pump; Model 801041). 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