Data / Medical devices / Implanted Tibial Electrical Urinary Continence Device
Implanted Tibial Electrical Urinary Continence Device (QXM): 4 FDA-registered makers in 4 countries
4 establishments in 4 countries are registered with the FDA to make Implanted Tibial Electrical Urinary Continence Device (product code QXM, Class 2, 21 CFR 876.5305). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 28, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QXM
- Device class
- 2
- Regulation
- 876.5305
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Israel | 1 |
| United States | 1 |
| Germany | 1 |
| Romania | 1 |
Makers of Implanted Tibial Electrical Urinary Continence Device
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 |
|---|---|---|---|---|---|---|---|---|
| Bluewind Medical Ltd. | Herzliya Central, Israel | Specification developer | 4 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bluewind Medical, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 2 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| OSYPKA GmbH | Rheinfelden Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Services Ro SRL | Oradea Bihor, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 28, 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.