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Sign in to claim this brandHISTOSONICS, INC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 16305 36th Avenue North, Plymouth, MN, 55446
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3027664504
- DUNS Number
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Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HistoSonics® Planning Tool | K252947 | FDA 510(k) | Class II | Active |
| HistoSonics | HISKT2000 | FDA UDI | N/A | Active |
| Edison | EDNTC1001 | FDA UDI | Class II | Active |
| Edison | EDNSA1001 | FDA UDI | Class II | Active |
| Edison | EDNTH0212 | FDA UDI | Class II | Active |
| Edison | EDNTC1001 | FDA UDI | Class II | Active |
| Edison | EDNCK2001 | FDA UDI | Class II | Active |
| Edison | EDNTH14 | FDA UDI | Class II | Active |
| Edison | EDNTH0814 | FDA UDI | Class II | Active |
| HistoSonics | HISFL1001 | FDA UDI | Class I | Active |
| HistoSonics | HISFK2001 | FDA UDI | Class I | Active |
| Edison | EDNTH12 | FDA UDI | Class II | Active |
| Edison System | K241902 | FDA 510(k) | Class II | Active |
| Edison System | DEN220087 | FDA 510(k) | Class II | Active |
| Edison System | K233466 | FDA 510(k) | Class II | Active |
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