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 Neurology ✕
7 devices
Cleared
Sep 24, 2026
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Neurology
27d
Cleared
Oct 27, 2023
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Neurology
28d
Cleared
Nov 11, 2022
Mapping Suction Probe
Neurology
487d
Cleared
Jan 07, 2022
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Neurology
179d
Cleared
Oct 06, 2011
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
Neurology
115d
Cleared
Mar 18, 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
Neurology
214d
Cleared
Oct 02, 1991
WALTER GRAPHTEK
Neurology
209d