Sorin Group Italia S.R.L. - FDA 510(k) Cleared Devices
61
Total
61
Cleared
0
Denied
55 devices
Cleared
Aug 29, 2014
MEMO 3D ReChord
Cardiovascular
17d
Cleared
Jun 06, 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Cardiovascular
48d
Cleared
Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...
Cardiovascular
27d
Cleared
Feb 12, 2013
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE...
Cardiovascular
14d
Cleared
Oct 17, 2012
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
Cardiovascular
30d
Cleared
Aug 24, 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
Cardiovascular
28d
Cleared
Aug 22, 2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
Cardiovascular
90d
Cleared
Jul 26, 2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL...
Cardiovascular
27d
Cleared
Jul 23, 2012
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL...
Cardiovascular
90d
Cleared
May 11, 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
Cardiovascular
109d
Cleared
Apr 05, 2012
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
Cardiovascular
119d
Cleared
Oct 14, 2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Cardiovascular
21d
Cleared
Mar 24, 2010
XRES BLOOD COLLECTION RESERVOIR
Cardiovascular
30d
Cleared
Jan 22, 2010
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
Cardiovascular
29d
Cleared
Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
Cardiovascular
28d
Cleared
Oct 19, 2009
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Cardiovascular
28d
Cleared
Aug 12, 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
Cardiovascular
13d
Cleared
Oct 29, 2008
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Cardiovascular
20d
Cleared
Feb 29, 2008
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL...
Cardiovascular
88d
Cleared
Oct 29, 2007
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL...
Cardiovascular
91d
Cleared
Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN...
Cardiovascular
26d
Cleared
Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN...
Cardiovascular
76d
Cleared
Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
Cardiovascular
25d
Cleared
Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH...
Cardiovascular
49d
Cleared
Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
Cardiovascular
86d