23 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THERMEDX, LLC
FDA registration
THERMEDX, LLC·4 products·🇺🇸 United States
Tubing Set - Single Lumen, Inflow with Dual Outflow
FDA UDI
THERMEDX, LLC·00860936000358·
Fluid Management System
FDA UDI
THERMEDX, LLC·00860936000327·
Luer Lock Set, Single Lumen
FDA UDI
THERMEDX, LLC·00860936000334·
Urology Set
FDA UDI
THERMEDX, LLC·00860936000365·Urology Set
Fluid Management System
FDA UDI
THERMEDX, LLC·00860936000310·
High Pressure Luer Lock Set, Single Lumen 300mmHg
FDA UDI
THERMEDX, LLC·00860936000341·
THERMEDX FLUIDSMART SYSTEM
FDA Adverse Event
Injury
·THERMEDX, LLC·Product code LGZ·November 28, 2016
UROLOGY SET
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·July 17, 2024
THERMEDX
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·December 11, 2023
THERMEDX
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·December 11, 2023
THERMEDX
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·December 11, 2023
THERMEDX
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·December 11, 2023
37-5 FLUID MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HIG·October 20, 2016
UROLOGY SET
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·June 9, 2025
THERMEDX HYSTEROSCOPY MACHINE
FDA Adverse Event
Other
·THERMEDX, LLC.·Product code HIG·March 26, 2015
UROLOGY SET
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·March 25, 2026
UROLOGY SET
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·March 25, 2026
LUER LOCK SET, SINGLE LUMEN
FDA Adverse Event
Malfunction
·THERMEDX, LLC·Product code HRX·November 19, 2019
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