637 results
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20ms
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Sources: EU EUDAMED, US FDA
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
FDA Recall
Terminated
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code QDI·January 18, 2022
CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·December 11, 2015
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
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 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011
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 TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 28, 2011
CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·December 7, 2011
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DWF·January 19, 2016
Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module, catalog 500A.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011
Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011