Terumo Europe N.V.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)July 8, 2025
K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)May 29, 2025
K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)April 4, 2025
K230951Terumo Injection Filter Needle (NF-3013RBKE05M)October 18, 2023
K212095SurGuard3 Safety Hypodermic NeedleAugust 22, 2022
K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-PackOctober 11, 2019
K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHFebruary 10, 2017
K151398K-Pack II Needle - 29G x 5/16 Thin WallJune 25, 2015
K150263K-Pack II Needle-21G x 2April 1, 2015
K133894SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)March 18, 2014
K133867SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)February 5, 2014
K132233K-PACK II NEEDLE - 27G X 3/4 THIN WALLSeptember 6, 2013
K11179727 G X 1/2 K-PACK SURSHIELD NEEDLESeptember 22, 2011
K110850K-PACK II NEEDLE- 27G & 30G THIN WALLJune 9, 2011
K110527K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USEJune 6, 2011
K100946INTRAVSCULAR ADMINISTRATION SETAugust 2, 2010
K083514TERUMO SYRINGE WITH/WITHOUT NEEDLEMay 22, 2009
K082820K-PACK II NEEDLE - 29G THIN WALLOctober 23, 2008
K072894SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)November 6, 2007
K07026450 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LBMay 29, 2007