GEMSS HEALTHCARE CO., LTD.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | November 16, 2023 |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | November 2, 2023 |