Syncardia Systems, LLC

1992 East Silverlake Road, Tucson, United States, 85713

28 devices 30 registrations
✕ EU (EUDAMED) ✕ AU (TGA)
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Devices

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Showing 1–20 of 28 devices

Device Name US UK CA AU EU
50cc temporary Total Artificial Heart (TAH-t) 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)
70cc temporary Total Artificial Heart (TAH-t) 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)
CARDIOWEST C 70 TOTAL ARTI. HEART (TAH-T) W/CIRCULATORY SYS SUPPORT CONSOLE 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)
CIRCULATORY SUPPORT SYSTEM CONSOLE (CSS CONSOLE) 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)
Companion 2 Air Hose Assembly (EU Configuration) 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)
Companion 2 Air Hose Assembly (FR Configuration) 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)
COMPANION 2 DRIVER SYSTEM Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
Companion Drivelines 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)
Companion Driver Caddy 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)
COMPANION DRIVE UNIT 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)
Companion External Battery 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)
Companion Hospital Cart 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)
Freedom Battery Charger 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)
FREEDOM DISCHARGE KIT 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)
Freedom Driver 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)
FREEDOM DRIVER SYSTEM 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)
Freedom Driver System Bags 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)
Freedom Driver System Discharge Kit - EU 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)
Freedom Onboard Battery 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)
FREEDOM STANDBY KIT Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
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