Monarch Medical Technologies
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0354-2020 | Class II | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) | October 1, 2019 |
| Z-1786-2019 | Class II | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 an | May 3, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241088 | EndoTool IV (3.1) | December 11, 2024 |
| K211160 | EndoTool SubQ 2.1 | October 28, 2021 |
| K201619 | EndoTool IV System | August 7, 2020 |
| K200443 | EndoTool IV 1.10 | March 17, 2020 |
| K142918 | EndoTool SubQ | April 24, 2015 |
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | April 17, 2014 |