Company ยท US
Monarch Medical Technologies
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NDC | Calculator, Drug Dose | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2024 | K241088 | EndoTool IV (3.1) Monarch Medical Technologies | NDC |
| Oct 28, 2021 | K211160 | EndoTool SubQ 2.1 Monarch Medical Technologies, LLC | NDC |
| Aug 7, 2020 | K201619 | EndoTool IV System Monarch Medical Technologies, LLC | NDC |
| Mar 17, 2020 | K200443 | EndoTool IV 1.10 Monarch Medical Technologies, LLC | NDC |
| Apr 24, 2015 | K142918 | EndoTool SubQ Monarch Medical Technologies | NDC |
| Apr 17, 2014 | K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) Monarch Medical Technologies | NDC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Monarch Medical Technologies EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) Terminated |
NDC | None listed |
| May 3, 2019 | Monarch Medical Technologies Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Open, Classified |
NDC | K132547 |