Data / Medical devices / Israel / Bluewind Medical Ltd.
Bluewind Medical Ltd.: FDA-registered device maker in Herzliya Central, Israel, 4 510(k) clearances
Bluewind Medical Ltd. is registered with the FDA (registration 3012239564) in Herzliya Central, Israel. It lists 1 device type. The FDA files 4 510(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
- 3012239564
- Address
- Building C, Eastern Side 4, Maskit, Herzliya Central, Israel, 4673304
- Owner or operator
- BlueWind Medical Ltd. (10088572)
- Roles
- Specification developer
- First device listed
- August 17, 2023
- Registered through
- 2026
- Brand names listed
- Revi Clinician Program, Revi Extend Implant, Revi Hub, Revi Implant, Revi System, Revi Wearable
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implanted Tibial Electrical Urinary Continence Device | QXM | 2 | 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 |
| May 2, 2024 | K240037 | Revi System | QXM | Substantially Equivalent | Bluewind Medical , Ltd. | accessdata.fda.gov |
| August 16, 2023 | DEN220073 | Revi System | QXM | Unknown | 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.