Data / Medical devices / Stimulator, Hypoglossal Nerve, Implanted, Apnea
Stimulator, Hypoglossal Nerve, Implanted, Apnea (MNQ): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MNQ
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Belgium | 2 |
| Israel | 1 |
| Switzerland | 1 |
Makers of Stimulator, Hypoglossal Nerve, Implanted, Apnea
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inspire Medical Systems Inc | Golden Valley, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 4 | 1 | api.fda.gov | |
| Inspire Medical Systems Inc | Golden Valley, MN, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nyxoah SA | Mont-Saint-Guibert Brabant Wallon, Belgium | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nyxoah SA Milmort | Herstal Liege, Belgium | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Avivomed, Inc | Roseville, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDR Manufacturing, Inc., DBA Keytronic | Oakdale, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Brooklyn Park, MN, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Enfield, CT, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatbatch Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osypka Medtec Inc. | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pronat Industries Ltd. | Emek Hefer Ind. Park Haifa, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swisstronics Contract Manufacturing AG | Bronschhofen Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.