Bluewind Medical, Inc. (specification developer, Salt Lake City, UT): 1 new FDA device listing, incl. implanted tibial electrical urinary continence device
Bluewind Medical, Inc. (Salt Lake City, Utah): 1 new FDA device listing, incl. implanted tibial electrical urinary continence device. Its amount of 1 is above the median of 2 (50th percentile). Dated 94 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 34 related UT DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Bluewind Medical, Inc. |
| Owner / operator | BlueWind Medical Ltd. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Salt Lake City, UT, US |
| New listings | 1 |
| Devices | Implanted Tibial Electrical Urinary Continence Device |
| Product codes | QXM |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | Revi System; Revi Extend Implant |
| First new listing | 2026-08-04 |
| Latest new listing | 2026-08-04 |
| FDA registration number | 3038988751 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (35 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-04
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (UT first): Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, · Zigg Design LLC (contract manufacturer, Nibley, UT) · Bard Access Systems, Inc. (other, Salt Lake City, UT) · Isomedix Operations Inc. (contract sterilizer, Sandy, UT) · Merit Medical Systems, Inc. (manufacturer, South Jordan, UT) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Bluewind Medical, Inc. and 35 Utah peers
- Utah DeviceEstablishmentPulse records like this one: 35
- Bluewind Medical, Inc.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $7,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Bluewind Medical, Inc. in Salt Lake City, Utah?
Bluewind Medical, Inc. (Salt Lake City, UT), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-08-04.
How does Bluewind Medical, Inc. compare to other Utah DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 94 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Bluewind Medical, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Bluewind Medical, Inc. | Salt Lake City, UT | 1 | 50th | 2026-08-04 |
| Centinel Spine, LLC | West Chester, PA | 3 | 77th | 2026-10-22 |
| TORNIER Inc. | Columbia City, IN | 3 | 77th | 2026-10-21 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Utah
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.