inomed Medizintechnik GmbH FDA Approvals

0 new drug approvals and 6 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
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress510(k)Sep 24, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Sep 24, 2026
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)510(k)Jun 13, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jun 13, 2025
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress510(k)Oct 27, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Oct 27, 2023
C2 Xplore510(k)Jan 27, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 27, 2023
Mapping Suction Probe510(k)Nov 11, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Nov 11, 2022
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress510(k)Jan 7, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 7, 2022