Sorin Group Italia S.R.L. is one of 126 FDA 510(k) medical device manufacturers from Italy in the dataset, ranked by real submission volume.
Sorin Group Italia S.R.L. - FDA 510(k) Cleared Devices
Recent clearances: Dual Stage Venous Cannulae, Inspire HCR and HCR DUAL cardiotomy reservoirs, ProtekDilate Vascular Access Kit
61
Total
61
Cleared
0
Denied
Sorin Group Italia S.R.L. has 61 FDA 510(k) cleared cardiovascular devices. Based in Mirandola, IT.
Latest FDA clearance: Jan 2026. Active since 1995.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LivaNova USA, Inc., Parexel Consulting, LLC and Sorin Group USA, Inc..
FDA 510(k) Regulatory Record - Sorin Group Italia S.R.L.
61 devices
Cleared
Jan 30, 2026
Dual Stage Venous Cannulae
Cardiovascular
70d
Cleared
Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
Cardiovascular
194d
Cleared
Dec 19, 2025
ProtekDilate Vascular Access Kit
Cardiovascular
31d
Cleared
Jun 27, 2025
Easyflow (103-200
Cardiovascular
119d
Cleared
May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
Cardiovascular
129d
Cleared
Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
Gastroenterology & Urology
192d
Cleared
Dec 20, 2024
KIDS Arterial Filters
Cardiovascular
86d
Cleared
Nov 18, 2024
MICRO Arterial Filters
Cardiovascular
124d
Cleared
Aug 16, 2024
XTRA Collection sets
Cardiovascular
106d
Cleared
Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
Cardiovascular
59d
Cleared
Feb 22, 2024
R501 - R502 aortic root cannulae with and without vent line (R501-15:...
Cardiovascular
29d
Cleared
Nov 16, 2023
D100 KIDS
Cardiovascular
163d
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