Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

65 results for "Sorin Group Italia S.R.L."
1–24 of 65
Search insights Median review: 77d Cleared: 100% Top manufacturer: Sorin Group Italia S.R.L. Lead specialty: Cardiovascular
Cleared Oct 01, 2026
Dual Stage Venous Cannulae
K263092 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Sep 28, 2026
Tri Stage Venous Cannulae
K262052 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 102d
Cleared Mar 11, 2026
Venous Return Cannulae
K250937 · DWF
LivaNova USA, Inc.
Cardiovascular · 348d
Cleared Jan 30, 2026
Dual Stage Venous Cannulae
K253671 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 70d
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 194d
Cleared Dec 19, 2025
ProtekDilate Vascular Access Kit
K253616 · DRE
Sorin Group Italia S.R.L.
Cardiovascular · 31d
Cleared Jul 10, 2025
RAP Femoral Venous Cannulae
K250283 · DWF
LivaNova USA, Inc.
Cardiovascular · 160d
Cleared Jun 27, 2025
Easyflow (103-200
K250610 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · DTR
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
K243264 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 192d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 124d
Cleared Aug 16, 2024
XTRA Collection sets
K241236 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Feb 22, 2024
R501 - R502 aortic root cannulae with and without vent line (R501-15:...
K240193 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Nov 16, 2023
D100 KIDS
K231652 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 163d
Cleared Jun 10, 2023
BMR 1900 PHISIO
K223361 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 219d
Cleared Jul 12, 2021
EOS PMP
K211495 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 60d
Cleared Nov 17, 2020
R501 aortic root cannula without vent line, R502 aortic root cannula with...
K200612 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 253d
Cleared Aug 13, 2020
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator,...
K201916 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 34d
Cleared Jun 12, 2020
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE...
K200683 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Aug 07, 2019
Revolution Centrifugal Blood Pump
K190650 · KFM
Sorin Group Italia S.R.L.
Cardiovascular · 147d
Cleared Apr 13, 2019
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy...
K190690 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Nov 16, 2018
PureFlex Arterial Cannulae
K180979 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 217d