204 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code FKX·April 24, 2014
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·March 28, 2008
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code FIK·April 3, 2014
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code KDI·May 21, 2013
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code KDJ·October 6, 2015
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
FDA Recall
Terminated
·ConvaTec·Product code EXB·March 7, 2008
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KPE·July 27, 2017
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DQO·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DQO·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012