Fussen Technology Co., Ltd. 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
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)510(k)Sep 30, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 30, 2026
Dental Computed Tomography X-ray System510(k)Nov 13, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 13, 2025