Mani, Inc. - Kiyohara Facility
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1468-2023 | Class II | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile | February 20, 2023 |
| Z-0557-2021 | Class II | MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular | October 27, 2020 |
| Z-0558-2021 | Class II | MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intrao | October 27, 2020 |