Chrysalis Intelligence · Sponsors · Terumo Europe N.V.

Terumo Europe N.V.

Leuven, BE · 5 510(k) clearances

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Total clearances

5

2022-08-22 → 2025-07-08

Last 12 months

0

Product codes

2

Most recent

2025-07-08

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FMI	Needle, Hypodermic, Single Lumen	Class II	General Hospital	4	2025-07-08
QYM	Ophthalmic Needle	Class II	General Hospital	1	2023-10-18

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2025-07-08	K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)	FMI	Class II	General Hospital
2025-05-29	K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	FMI	Class II	General Hospital
2025-04-04	K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	FMI	Class II	General Hospital
2023-10-18	K230951	Terumo Injection Filter Needle (NF-3013RBKE05M)	QYM	Class II	General Hospital
2022-08-22	K212095	SurGuard3 Safety Hypodermic Needle	FMI	Class II	General Hospital