4 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
FDA Recall
Terminated
·Thermedx LLC·Product code OJR·February 10, 2014
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
FDA Recall
Terminated
·Thermedx LLC·Product code HIG·September 1, 2014
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
FDA Enforcement
Class II
·Terminated·Thermedx LLC·April 29, 2015
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
FDA Enforcement
Class II
·Terminated·Thermedx LLC·September 3, 2014