Agfa N.V. 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
VALORY510(k)Nov 18, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2021
DR 800 with DSA, DR 800510(k)Aug 31, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 31, 2021
DX-D Imaging Package with XD Detectors510(k)Jul 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2021