23 results · 32ms · Sources: EU EUDAMED, 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