Enbio Group AG 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
Enbio PRO510(k)Feb 26, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 26, 2026
Enbio S510(k)Feb 22, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Feb 22, 2022
Enbio S510(k)Oct 29, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 29, 2021