Terumo Europe N.V. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)510(k)Jul 8, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 8, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)510(k)May 29, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	May 29, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)510(k)Apr 4, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 4, 2025
Terumo Injection Filter Needle (NF-3013RBKE05M)510(k)Oct 18, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 18, 2023
SurGuard3 Safety Hypodermic Needle510(k)Aug 22, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 22, 2022