QYM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ophthalmic Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- FDA definition
- An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (K242073) | Tsk Laboratory International Japan KK | 2024-10-23 |
| Terumo Injection Filter Needle (NF-3013RBKE05M) (K230951) | Terumo Europe N.V. | 2023-10-18 |
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Every clearance here is in the API, with alerts when new ones post.