Data / Medical devices / United States / Thermedx, LLC
Thermedx, LLC: FDA-registered device maker in Solon, OH, United States, 3 510(k) clearances
Thermedx, LLC is registered with the FDA (registration 3007495879) in Solon, OH, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 5, 2017. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007495879
- Address
- 31200 Solon Road Unit 1, Solon, OH, United States, 44139
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 21, 2022
- Registered through
- 2026
- Brand names listed
- LL0002 FluidSmart Inflow Tube Set, LL0002 Luer Lock Set Single Lumen, LL0004 - Tubing Set Single Lumen Inflow with Dual Outflow, LL0004 FluidSmart Inflow/Outflow Tube Set, LL0006 FluidSmart Urology Tube Set, P01790 ThermaClear Inflow Tube Set, P01918 ThermaClear Scope Outflow Tube Set, P2000 FluidSmart Fluid Management system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Insufflator, Hysteroscopic | HIG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubing And Tubing/Filter Fits | NVT | 1 | Manufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2017 | K172048 | FluidSmart | HIG | Substantially Equivalent | Thermedx, LLC | accessdata.fda.gov |
| June 20, 2014 | K133799 | THERMEDX FLUID MANAGMENT SYSTEM | HIG | Substantially Equivalent | Thermedx, LLC | accessdata.fda.gov |
| July 23, 2010 | K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | HIG | Substantially Equivalent | Thermedx, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 1, 2014 | 69996 | Class II | Terminated | 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 orthoped | To correct software bugs that could affect the ability to accurately measure fluid deficit. | accessdata.fda.gov |
| February 10, 2014 | 68986 | Class II | Terminated | 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 a | A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. | accessdata.fda.gov |
Compare with other makers
- All makers of Arthroscope
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Insufflator, Hysteroscopic
- All makers of Tubing And Tubing/Filter Fits
Updated September 5, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.