799 International Parkway, Sunrise, United States, 33325
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| BOLTON PTA CATHETER | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Relay (Custom Made) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Relay Custom-Made Device | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| RelayNBS Plus Thoracic Stent-Graft System | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| RelayPlus Thoracic Stent-Graft System | Registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| RelayPro | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| RelayPro Thoracic Stent-Graft System | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| TREO | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| TREO® Abdominal Stent-Graft System | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| TREO (Custom Made) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| TREO Custom-Made Device | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| TREO Fit Custom-Made Device | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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