Thermedx, LLC
Thermedx, LLC holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2021, with 2 FDA device recalls on record.
Top product codes for Thermedx, LLC
FDA recalls by Thermedx, LLC
- Z-1463-2015 — 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 orthopedic procedures.
- Z-2555-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Thermedx, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.