Terumo Europe N.V.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24

Categories0

Latest FDA decision

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
510(k)	K132233	K-PACK II NEEDLE - 27G X 3/4 THIN WALL	FMI	2013-09-06	View
510(k)	K111797	27 G X 1/2 K-PACK SURSHIELD NEEDLE	FMI	2011-09-22	View
510(k)	K110850	K-PACK II NEEDLE- 27G & 30G THIN WALL	FMI	2011-06-09	View
510(k)	K110527	K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE	FMI	2011-06-06	View
510(k)	K100946	INTRAVSCULAR ADMINISTRATION SET	FPA	2010-08-02	View
510(k)	K083514	TERUMO SYRINGE WITH/WITHOUT NEEDLE	FMF	2009-05-22	View
510(k)	K082820	K-PACK II NEEDLE - 29G THIN WALL	FMI	2008-10-23	View
510(k)	K072894	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)	FPA	2007-11-06	View
510(k)	K070264	50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB	FMF	2007-05-29	View
510(k)	K070547	SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)	FPA	2007-05-25	View
510(k)	K070362	SURFLO WINGED INFUSION SET	FPA	2007-05-07	View
510(k)	K062608	29G AND 30G K-PACK II NEEDLE	FMI	2006-09-15	View
510(k)	K053413	TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES	FMF	2006-04-06	View