Panels › General, Plastic Surgery › Product code PZL · Class 2
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Regulation 878.4685
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Softwave/Trt, LLC | 2 | 0 |
| Tissue Regeneration Technologies | 2 | 0 |
| Curative Sound Therapeutics | 1 | 0 |
| E.M.S Electro Medical Systems S.A | 1 | 0 |
| Sanuwave, Inc. | 1 | 0 |
| Storz Medical AG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2025 | K243279 | DOLORCLAST Focused Shock Waves E.M.S Electro Medical Systems S.A, CH | PZL |
| Jul 2, 2025 | K250779 | CS-Pro MED Curative Sound Therapeutics | PZL |
| Jul 9, 2024 | K233937 | OW100S Softwave/Trt, LLC | PZL |
| Sep 1, 2023 | K231710 | OW100S Softwave/Trt, LLC | PZL |
| Feb 21, 2021 | K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece Storz Medical AG, CH | PZL |
| Aug 28, 2020 | K200926 | OrthoGold 100 Tissue Regeneration Technologies, LLC | PZL |
| Nov 26, 2019 | K191961 | OrthoGold Tissue Regeneration Technologies | PZL |
| Dec 28, 2017 | DEN160037 | dermaPACE System Sanuwave, Inc. | PZL |
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