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Sorin Group Italia S.R.L. FDA Approvals
0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Dual Stage Venous Cannulae510(k)Jan 30, 2026Cardiovascular |
| Inspire HCR and HCR DUAL cardiotomy reservoirs510(k)Dec 22, 2025Cardiovascular |
| ProtekDilate Vascular Access Kit510(k)Dec 19, 2025Cardiovascular |
| Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)510(k)Jun 27, 2025Cardiovascular |
| VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)510(k)May 30, 2025Cardiovascular |
| DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)510(k)Apr 25, 2025Gastroenterology, Urology |
| KIDS Arterial Filters510(k)Dec 20, 2024Cardiovascular |
| MICRO Arterial Filters510(k)Nov 18, 2024Cardiovascular |
| XTRA Collection sets; XTRA Sequestration set X510(k)Aug 16, 2024Anesthesiology |
| XTRA Autotransfusion System (with XTRA Bowl sets)510(k)Apr 29, 2024Anesthesiology |
| R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)510(k)Feb 22, 2024Cardiovascular |
| D100 KIDS; D101 KIDS510(k)Nov 16, 2023Cardiovascular |
| BMR 1900 PHISIO510(k)Jun 10, 2023Cardiovascular |
| EOS PMP510(k)Jul 12, 2021Cardiovascular |