Inomed Medizintechnik GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Inomed Medizintechnik GmbH - FDA 510(k) Cleared Devices
Recent clearances: 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, C2 Xplore
Inomed Medizintechnik GmbH, is a medical device manufacturer specializing in intraoperative neuromonitoring and surgical navigation systems. The company operates with a manufacturing facility in Emmendingen, Germany.
Inomed has maintained a strong FDA 510(k) regulatory record since 1991. The company has received 10 FDA 510(k) clearances from 10 total submissions, with the most recent clearance in 2025. This demonstrates continued active development and market engagement in specialized surgical technologies.
The company's cleared device portfolio spans neurology and otolaryngology applications. Core product lines include intraoperative neuromonitoring systems, neurostimulation devices, and surgical mapping probes. Additional cleared devices address thyroid surgery, pain management, and functional neurosurgery procedures.
Explore the complete list of device names, product codes, and individual clearance dates in the database to review Inomed's full regulatory history and current cleared offerings.