2880 Main Street, Hopkinton, United States, 12965
Showing 1–20 of 113 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Balloon in Balloon Catheter | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| BIB | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| BIB (BALLOON IN BALLOON) CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| BIB BALLOON IN BALLOON STENT PLACEMENT CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| BIB Catheter | 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) |
| BIB PTA BALLOON 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) |
| BIB PTA Catheter | 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) |
| BIB Stent Placement 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) |
| Bonhoeffer Mitral Kit | 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) |
| COEfficient | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| COEFFICIENT PTV CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Covered CP Stent | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Covered Mounted CP Stent | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| CP Stent | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42 | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Custom BIB Catheter | 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) |
| Custom Covered CP Stent | 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) |
| D'Vill Introducer | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| G-ARMOR COVERED MOUNTED STENT | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| G-ARMOR COVERED STENT | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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