Enraf-Nonius, 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
Compact II510(k)Sep 12, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Sep 12, 2025
Curapuls 670510(k)Jun 25, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jun 25, 2025
Sonopuls 190510(k)Oct 24, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 24, 2023