Companion Medical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0741-2023 | Class II | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105E | November 8, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201337 | InPen System | June 18, 2020 |
| K190487 | InPen Dose Calculator | February 18, 2020 |
| K192841 | InPen System | February 10, 2020 |
| K181327 | InPen Dose Calculator | July 6, 2018 |
| K160629 | InPen | July 26, 2016 |