Data / Medical devices / Implanted Electrical Device Intended For Treatment Of Fecal Incontinence / United States
FDA-registered makers of Implanted Electrical Device Intended For Treatment Of Fecal Incontinence in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Implanted Electrical Device Intended For Treatment Of Fecal Incontinence (product code QON). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
- Product code
- QON
- Country
- United States
Makers of Implanted Electrical Device Intended For Treatment Of Fecal Incontinence in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Axonics, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Wabasha, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Enfield, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | 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.