3D-Shaper Medical S.L FDA Approvals

0 new drug approvals and 2 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
3D-SHAPER510(k)Sep 5, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 5, 2025
3D-SHAPER510(k)Dec 9, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 9, 2022