Data / Medical devices / Germany / Inomed Medizintechnik GMBH
Inomed Medizintechnik GMBH: FDA-registered device maker in EMMENDINGEN Baden-Wurttemberg, Germany, 11 510(k) clearances
Inomed Medizintechnik GMBH is registered with the FDA (registration 3004753785) in EMMENDINGEN Baden-Wurttemberg, Germany. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 24, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004753785
- Address
- Im Hausgruen 29, EMMENDINGEN Baden-Wurttemberg, Germany, D-79312
- Owner or operator
- INOMED MEDIZINTECHNIK GMBH (9065889)
- Roles
- Manufacturer
- First device listed
- December 3, 2009
- Registered through
- 2027
- Brand names listed
- Mapping Suction Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Substantially Equivalent | inomed Medizintechnik GmbH | accessdata.fda.gov |
| June 13, 2025 | K242852 | 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) | ETN | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| October 27, 2023 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| January 27, 2023 | K223254 | C2 Xplore | ETN | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| November 11, 2022 | K212164 | Mapping Suction Probe | ETN | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| January 7, 2022 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| February 1, 2016 | K152505 | C2 NerveMonitor System | ETN | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| October 6, 2011 | K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | GWF | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| November 18, 2009 | K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | ETN | Substantially Equivalent | Inomed Medizintechnik GmbH | accessdata.fda.gov |
| May 17, 2001 | K003486 | STEREOTACTIC FRAME BASED SYSTEM | HAW | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| March 23, 1990 | K892425 | STP COMPLETE MODULE SET | IYE | Substantially Equivalent | Leibinger & Fischer , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Stimulator, Nerve
- All makers of Accelerator, Linear, Medical
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Electromyograph, Diagnostic
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.