Inomed Medizintechnik GmbH - FDA 510(k) Cleared Devices
Recent clearances: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, 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), ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Inomed Medizintechnik GmbH Ear, Nose, Throat ✕
4 devices
Cleared
Jun 13, 2025
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845),...
Ear, Nose, Throat
266d
Cleared
Jan 27, 2023
C2 Xplore
Ear, Nose, Throat
98d
Cleared
Feb 01, 2016
C2 NerveMonitor System
Ear, Nose, Throat
152d
Cleared
Nov 18, 2009
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
Ear, Nose, Throat
148d