5 results
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7ms
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Sources: EU EUDAMED, US FDA
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Enforcement
Class II
·Terminated·Boddingtons Plastics Ltd·April 22, 2020
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·June 24, 2015
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·June 10, 2015
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·September 2, 2015
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
FDA Enforcement
Class II
·Terminated·Medrad Mr Inc·January 29, 2014