Terumo Europe N.V. - FDA 510(k) Cleared Devices

Cleared Jul 08, 2025

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

K251447 · FMI

General Hospital · 60d

Cleared May 29, 2025

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

K243309 · FMI

General Hospital · 220d

Cleared Apr 04, 2025

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

K243581 · FMI

General Hospital · 141d

Cleared Oct 18, 2023

Terumo Injection Filter Needle (NF-3013RBKE05M)

K230951 · QYM

General Hospital · 197d

Cleared Aug 22, 2022

SurGuard3 Safety Hypodermic Needle

K212095 · FMI

General Hospital · 412d

Cleared Oct 11, 2019

K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”...

K192057 · FMI

General Hospital · 71d

Cleared Feb 10, 2017

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

K161606 · FMF

General Hospital · 245d

Cleared Jun 25, 2015

K-Pack II Needle - 29G x 5/16 Thin Wall

K151398 · FMI

General Hospital · 30d

Cleared Apr 01, 2015

K-Pack II Needle-21G x 2

K150263 · FMI

General Hospital · 56d

Cleared Mar 18, 2014

SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)

K133894 · FPA

General Hospital · 88d

Cleared Feb 05, 2014

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

K133867 · FPA

General Hospital · 47d

Cleared Sep 06, 2013

K-PACK II NEEDLE - 27G X 3/4 THIN WALL

K132233 · FMI

General Hospital · 50d