Medical Device Manufacturer · BE , Leuven

Terumo Europe N.V.

28 submissions · 28 cleared · Since 1999
28
Total
28
Cleared
0
Denied

Terumo Europe N.V. — FDA 510(k) Submissions

Terumo Europe N.V. has submitted 28 FDA 510(k) premarket notifications since 1999, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Hypodermic, Single Lumen, Set, Administration, Intravascular, Syringe, Piston, Tubes, Vials, Systems, Serum Separators, Blood Collection, Ophthalmic Needle . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · FMI Needle, Hypodermic,... · General Hospital
Jul 2025 60d
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
K243309 · FMI Needle, Hypodermic,... · General Hospital
May 2025 220d
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
K243581 · FMI Needle, Hypodermic,... · General Hospital
Apr 2025 141d
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951 · QYM Ophthalmic Needle · General Hospital
Oct 2023 197d
SurGuard3 Safety Hypodermic Needle
K212095 · FMI Needle, Hypodermic,... · General Hospital
Aug 2022 412d
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
K192057 · FMI Needle, Hypodermic,... · General Hospital
Oct 2019 71d
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606 · FMF Syringe, Piston · General Hospital
Feb 2017 245d
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · FMI Needle, Hypodermic,... · General Hospital
Jun 2015 30d
K-Pack II Needle-21G x 2
K150263 · FMI Needle, Hypodermic,... · General Hospital
Apr 2015 56d
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894 · FPA Set, Administration,... · General Hospital
Mar 2014 88d
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867 · FPA Set, Administration,... · General Hospital
Feb 2014 47d
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · FMI Needle, Hypodermic,... · General Hospital
Sep 2013 50d
27 G X 1/2 K-PACK SURSHIELD NEEDLE
K111797 · FMI Needle, Hypodermic,... · General Hospital
Sep 2011 90d
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · FMI Needle, Hypodermic,... · General Hospital
Jun 2011 73d
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · FMI Needle, Hypodermic,... · General Hospital
Jun 2011 102d
INTRAVSCULAR ADMINISTRATION SET
K100946 · FPA Set, Administration,... · General Hospital
Aug 2010 118d
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · FMF Syringe, Piston · General Hospital
May 2009 177d
K-PACK II NEEDLE - 29G THIN WALL
K082820 · FMI Needle, Hypodermic,... · General Hospital
Oct 2008 28d
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K072894 · FPA Set, Administration,... · General Hospital
Nov 2007 26d
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · FMF Syringe, Piston · General Hospital
May 2007 120d
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547 · FPA Set, Administration,... · General Hospital
May 2007 88d
SURFLO WINGED INFUSION SET
K070362 · FPA Set, Administration,... · General Hospital
May 2007 89d
29G AND 30G K-PACK II NEEDLE
K062608 · FMI Needle, Hypodermic,... · General Hospital
Sep 2006 10d
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · FMF Syringe, Piston · General Hospital
Apr 2006 120d
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
K052887 · FPA Set, Administration,... · General Hospital
Dec 2005 56d
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