Tecres S.P.A. FDA Approvals

0 new drug approvals and 3 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
InterSpace GV Hip Spacer510(k)Aug 6, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 6, 2025
Bone Cement Genta, Bone Cement HV, Bone Cement LV510(k)Jan 9, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 9, 2023
KYPHON VuE Bone Cement510(k)Apr 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 18, 2022