Terumo Europe N.V.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories3
Latest FDA decision2025-07-08
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | FMI | 2025-07-08 | View |
| 510(k) | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FMI | 2025-05-29 | View |
| 510(k) | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | FMI | 2025-04-04 | View |
| 510(k) | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | QYM | 2023-10-18 | View |
| 510(k) | K212095 | SurGuard3 Safety Hypodermic Needle | FMI | 2022-08-22 | View |
| 510(k) | K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall | FMI | 2019-10-11 | View |
| 510(k) | K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | FMF | 2017-02-10 | View |
No matching devices.
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