Terumo Europe N.V. - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
Terumo Europe N.V. has 28 FDA 510(k) cleared general hospital devices. Based in Leuven, BE.
Latest FDA clearance: Jul 2025. Active since 1999.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Terumo Europe N.V.
28 devices
Cleared
Jul 08, 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
General Hospital
60d
Cleared
May 29, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
General Hospital
220d
Cleared
Apr 04, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
General Hospital
141d
Cleared
Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
General Hospital
197d
Cleared
Aug 22, 2022
SurGuard3 Safety Hypodermic Needle
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”...
General Hospital
71d
Cleared
Feb 10, 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
General Hospital
245d
Cleared
Jun 25, 2015
K-Pack II Needle - 29G x 5/16 Thin Wall
General Hospital
30d
Cleared
Apr 01, 2015
K-Pack II Needle-21G x 2
General Hospital
56d
Cleared
Mar 18, 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
General Hospital
88d
Cleared
Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
General Hospital
47d
Cleared
Sep 06, 2013
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
General Hospital
50d