Thermedx LLC
FDA Regulatory Profile
Thermedx LLC appears in FDA public data with 2 recalls, 5 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1463-2015, Class II) was initiated on September 1, 2014. Its most recent 510(k) clearance was granted on November 4, 2021.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1463-2015 | Class II | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and dis | September 1, 2014 |
| Z-2555-2014 | Class II | The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, | February 10, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210628 | X-FLO Fluid Management System | November 4, 2021 |
| K172048 | FluidSmart | September 5, 2017 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | June 20, 2014 |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 | March 25, 2011 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | July 23, 2010 |