Company ยท US
Thermedx, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2021. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2021 | K210628 | X-FLO Fluid Management System Thermedx, LLC | HIG |
| Sep 5, 2017 | K172048 | FluidSmart Thermedx, LLC | HIG |
| Jun 20, 2014 | K133799 | THERMEDX FLUID MANAGMENT SYSTEM Thermedx, LLC | HIG |
| Mar 25, 2011 | K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 Thermedx, LLC | GEI |
| Jul 23, 2010 | K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 Thermedx, LLC | HIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2015 | Thermedx LLC 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, Terminated |
HIG | K091939 K133799 |
| Aug 27, 2014 | Thermedx LLC 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 f Terminated |
OJR | K091939 K133799 |