Data / Medical devices / United States / Bluewind Medical, Inc.
Bluewind Medical, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances
Bluewind Medical, Inc. is registered with the FDA (registration 3038988751) in Salt Lake City, UT, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038988751
- Address
- 250 E 200 S Ste 1600, Salt Lake City, UT, United States, 84111
- Owner or operator
- BlueWind Medical Ltd. (10088572)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 7, 2026
- Registered through
- 2026
- Brand names listed
- Revi Extend Implant, Revi System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implanted Tibial Electrical Urinary Continence Device | QXM | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 28, 2026 | K253651 | Revi System | QXM | Substantially Equivalent | Bluewind Medical , Ltd. | accessdata.fda.gov |
| December 12, 2025 | K252391 | Revi System | QXM | Substantially Equivalent | Bluewind Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
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.