Palodex Group OY 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
Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)510(k)Sep 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2024
Orthopantomograph OP 3D LX510(k)Jun 9, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 9, 2023