Screenpoint Medical B.V. FDA Approvals

0 new drug approvals and 5 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
Transpara (2.1.0)510(k)Aug 14, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 14, 2026
Transpara (2.1.0)510(k)Nov 25, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 25, 2024
Transpara Density 1.0.0510(k)Dec 11, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 11, 2023
Transpara 1.7.2510(k)Aug 3, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 3, 2022
Transpara 1.7.0510(k)Jun 2, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 2, 2021