Envoy Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2590-2018 | Class II | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expi | June 28, 2018 |
| Z-0750-2013 | Class II | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implanta | January 9, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080032 | ENVOYCEM, MODEL 1640 | February 28, 2008 |