Medical Device Manufacturer · DE , Emmendingen

Inomed Medizintechnik GmbH

10 submissions · 10 cleared · Since 1991
10
Total
10
Cleared
0
Denied

Inomed Medizintechnik GmbH — FDA 510(k) Submissions

Inomed Medizintechnik GmbH has submitted 10 FDA 510(k) premarket notifications since 1991, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Stimulator, Electrical, Evoked Response, Full-montage Standard Electroencephalograph, Electrode, Depth . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
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)
K242852 · ETN Stimulator, Nerve · Ear, Nose, Throat
Jun 2025 266d
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K233292 · GWF Stimulator, Electrical,... · Neurology
Oct 2023 28d
C2 Xplore
K223254 · ETN Stimulator, Nerve · Ear, Nose, Throat
Jan 2023 98d
Mapping Suction Probe
K212164 · ETN Stimulator, Nerve · Neurology
Nov 2022 487d
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K212166 · GWF Stimulator, Electrical,... · Neurology
Jan 2022 179d
C2 NerveMonitor System
K152505 · ETN Stimulator, Nerve · Ear, Nose, Throat
Feb 2016 152d
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647 · GWF Stimulator, Electrical,... · Neurology
Oct 2011 115d
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
K091874 · ETN Stimulator, Nerve · Ear, Nose, Throat
Nov 2009 148d
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · GZL Electrode, Depth · Neurology
Mar 2005 214d
WALTER GRAPHTEK
K910972 · GWQ Full-montage Standard... · Neurology
Oct 1991 209d
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