22 Cherry Hill Drive, Danvers, United States, 01923
Showing 1–20 of 96 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 14Fr Low Profile Introducer Kit | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - ARTERIAL VENTRICLE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - CART - UNCRATED AND CRATED | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - MAIN UNIT - UNCRATED AND CRATED | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - MALLEABLE/SHORT APICAL CANNULA | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - PORTABLE DRIVER BATTERY PACK | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - SILICONE ARTERIAL CANNULA ASSEMBLY | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYSTEM - VENTRICULAR/ATRIAL CANNULA | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AB5000 CIRCULATORY SUPPORT SYST - PORTABLE DRIVER - CONSOLE UNCRATED/CRATED | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ABIODENT PERIOTEMP(R) SYSTEM | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Abiomed 14Fr Low Profile Introducer Kit | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Abiomed 14Fr Low Profile Introducer Set | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Abiomed 23 Fr Sheath | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ABIOMED BODY LEAD ANALYZER MODEL 200/20 | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ABIOMED PERIOTEMP(TM) PROBE | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AIC SOFTWARE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Automated Impella Controller | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Axillary Insertion Graft Lock | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| AXILLARY INSERTION KIT FOR IMPELLA 5.0 | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM - BLOOD PUMP & CANNULA SET | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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