Planmed OY 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
Planmed XFI510(k)Sep 26, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 26, 2025
Planmed Clarity 2D, Planmed Clarify S510(k)Jul 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2022
Planmed Verity510(k)Apr 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 28, 2022