Panels › Gastroenterology, Urology › Product code QXM · Class 2
Implanted Tibial Electrical Urinary Continence Device
Regulation 876.5305
2510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QXM
| Company | 510(k)s | Recalls |
|---|---|---|
| Bluewind Medical , Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2026 | K253651 | Revi System Bluewind Medical , Ltd., IL | QXM |
| Dec 12, 2025 | K252391 | Revi System Bluewind Medical , Ltd., IL | QXM |
| May 2, 2024 | K240037 | Revi System Bluewind Medical , Ltd., IL | QXM |
| Aug 16, 2023 | DEN220073 | Revi System Bluewind Medical , Ltd., IL | QXM |
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