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."
25–48 of 65
Search insights Median review: 77d Cleared: 100% Top manufacturer: Sorin Group Italia S.R.L. Lead specialty: Cardiovascular
Cleared Mar 16, 2018
MEMO 4D
K180411 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Mar 15, 2018
INSPIRE 6M Hollow Fiber Oxygenator
K180448 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Jun 16, 2017
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
K162215 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 312d
Cleared Mar 08, 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 258d
Cleared Nov 06, 2015
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 134d
Cleared Jun 11, 2015
EOS PMP, EOS PMP Integrated
K150489 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Aug 29, 2014
MEMO 3D ReChord
K142221 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 17d
Cleared Jun 06, 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
K131103 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 48d
Cleared Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...
K130433 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Feb 12, 2013
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE...
K130209 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 14d
Cleared Oct 17, 2012
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K122844 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Aug 24, 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K122254 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 22, 2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
K121536 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared Jul 26, 2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL...
K121909 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Jul 23, 2012
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL...
K121229 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared May 11, 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K120185 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 109d
Cleared Apr 05, 2012
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K113626 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared Oct 14, 2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 21d
Cleared Sep 06, 2011
XTRA
K112245 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 33d
Cleared Apr 07, 2011
XVAC
K110782 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 17d
Cleared Nov 23, 2010
PREASSEMBLED SURGICAL WASH SET
K103202 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 22d
Cleared Oct 05, 2010
XTRA AUTOTRANSFUSION SYSTEM
K101586 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 120d
Cleared Mar 24, 2010
XRES BLOOD COLLECTION RESERVOIR
K100507 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Jan 22, 2010
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
K093986 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 29d