Otsuka America Pharmaceutical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251088 | Otsuka Digital Feedback Device | June 30, 2025 |
| K231209 | Rejoyn | March 30, 2024 |
| K223463 | Otsuka Digital Feedback Device-RW | August 11, 2023 |