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."
49–65 of 65
Search insights Median review: 77d Cleared: 100% Top manufacturer: Sorin Group Italia S.R.L. Lead specialty: Cardiovascular
Cleared Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Oct 19, 2009
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K092895 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 12, 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K092315 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 13d
Cleared Nov 19, 2008
SH14 HEMOCONCENTRATOR
K081313 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 194d
Cleared Oct 29, 2008
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K083021 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 20d
Cleared Feb 29, 2008
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL...
K073380 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Oct 29, 2007
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL...
K072091 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 91d
Cleared Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN...
K072308 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN...
K063255 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 76d
Cleared Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 25d
Cleared Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH...
K061031 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 49d
Cleared Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE...
K010974 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 77d
Cleared Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE...
K002019 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 270d
Cleared Jul 28, 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 85d
Cleared Aug 26, 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 54d
Cleared Jun 02, 1995
AORTIC ARCH CANNULAS
K943934 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 294d