Inomed Medizintechnik GmbH
EMMENDINGEN Baden-Wurttemberg, DE
INOMED MEDIZINTECHNIK GMBH appears in FDA device records in EMMENDINGEN Baden-Wurttemberg, DE. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Inomed Medizintechnik GmbH between 1991 and 2025. The busiest year on record is 2022, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Substantially Equivalent | |
| K223254 | C2 Xplore | ETN | Substantially Equivalent | |
| K212164 | Mapping Suction Probe | ETN | Substantially Equivalent | |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Substantially Equivalent | |
| K152505 | C2 NerveMonitor System | ETN | Substantially Equivalent | |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | GWF | Substantially Equivalent | |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | ETN | Substantially Equivalent | |
| K042208 | ISIS MER SYSTEM/ELEKTA MER SYSTEM | GZL | Substantially Equivalent | |
| K910972 | WALTER GRAPHTEK | GWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004753785 | 3004753785 | INOMED MEDIZINTECHNIK GMBH | IM HAUSGRUEN 29, EMMENDINGEN Baden-Wurttemberg D-79312 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IKDCable, Electrode
- GZLElectrode, Depth
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- HAWNeurological Stereotaxic Instrument
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- GWEStimulator, Photic, Evoked Response
- BTRTube, Tracheal (W/Wo Connector)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain