Panels › General Hospital › Product code QYM · Class 2
Ophthalmic Needle
Regulation 880.5570
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QYM
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Europe N.V. | 1 | 0 |
| Tsk Laboratory International Japan KK | 1 | 0 |
| Tsk Laboratory, Japan | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2026 | K262516 | TSK OptiXion Tsk Laboratory, Japan, JP | QYM |
| Oct 23, 2024 | K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) Tsk Laboratory International Japan KK, JP | QYM |
| Oct 18, 2023 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) Terumo Europe N.V., BE | QYM |
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