Isys Medizintechnik GmbH FDA Approvals

0 new drug approvals and 2 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
Micromate Navi+510(k)Oct 10, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 10, 2023
MICROMATE510(k)Jun 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 22, 2021