Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Thermedx LLC with 5 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Nov 4, 2021: X-FLO Fluid Management System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 4, 2021 | X-FLO Fluid Management SystemK210628 · HIG | 510(k) clearances |
| Sep 5, 2017 | FluidSmartK172048 · HIG | 510(k) clearances |
| Sep 1, 2014 | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficClass II · To correct software bugs that could affect the ability to accurately measure fluid deficit. | Device recalls |
| Jun 20, 2014 | THERMEDX FLUID MANAGMENT SYSTEMK133799 · HIG | 510(k) clearances |
| Feb 10, 2014 | The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to aClass II · A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of t | Device recalls |
| Mar 25, 2011 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240K102275 · GEI | 510(k) clearances |
| Jul 23, 2010 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000K091939 · HIG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
