77 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JBP·October 6, 2010
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JBP·April 27, 2005
Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JBP·December 3, 2010
Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JBP·August 18, 2009
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
FDA Recall
Terminated
·Abbott Laboratories·Product code JBP·March 16, 2005
Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JBP·August 18, 2009
Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JBP·May 5, 2009
i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JBP·October 6, 2010
Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.
FDA Recall
Terminated
·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code DXN·October 12, 2011
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·September 8, 2021
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Recall
Terminated
·Cardiovascular Systems Inc·Product code MCW·July 21, 2021
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·September 5, 2018
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code MPB·July 12, 2018
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·February 14, 2018
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·February 14, 2018
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·September 5, 2018
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code MPB·July 12, 2018
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Ltd.·December 16, 2020