Hantech Medical Device Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | September 27, 2023 |
| K222739 | Disposable Insulin Pen Needle | April 6, 2023 |
| K222672 | Disposable Insulin Syringe | March 6, 2023 |
| K221038 | Disposable Medical Masks | September 1, 2022 |
| K220603 | Disposable Medical Safety Hypodermic Needle | August 23, 2022 |