Nucletron B.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
LumenCare Azure510(k)Jul 24, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 24, 2026
Rectal Applicator510(k)Dec 19, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 19, 2025
Esteya510(k)Jan 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 11, 2022