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Terumo Cardiovascular Systems Corp.

43 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (K153140)Terumo Cardiovascular Systems Corp.2015-12-02
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658)Terumo Cardiovascular Systems Corp.2014-07-25
ADVANCED PERFUSION SYSTEM 1 (K131041)Terumo Cardiovascular Systems Corp.2014-02-20
SARNS SOFT-FLOW AORTIC CANNULA (K132451)Terumo Cardiovascular Systems Corp.2014-02-18
SARNS HIGH FLOW AORTIC ARCH CANNULA (K133151)Terumo Cardiovascular Systems Corp.2014-02-03
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K130333)Terumo Cardiovascular Systems Corp.2013-03-13
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA (K130359)Terumo Cardiovascular Systems Corp.2013-03-13
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039)Terumo Cardiovascular Systems Corp.2012-11-20
TLINK DATA MANAGEMENT SYSTEM (DMS) (K113214)Terumo Cardiovascular Systems Corp.2012-02-07
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, (K112587)Terumo Cardiovascular Systems Corp.2011-12-19
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789)Terumo Cardiovascular Systems Corp.2010-05-12
TERUMO PRESSURE ISOLATOR (K092644)Terumo Cardiovascular Systems Corp.2009-12-10
TERUMO PALL AL3X ARTERIAL FILTER (K083747)Terumo Cardiovascular Systems Corp.2009-08-20
TERUMO PALL AL6X ARTERIAL FILTER (K083834)Terumo Cardiovascular Systems Corp.2009-04-17
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) (K090878)Terumo Cardiovascular Systems Corp.2009-04-03
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM (K082321)Terumo Cardiovascular Systems Corp.2009-02-13
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 (K083194)Terumo Cardiovascular Systems Corp.2009-01-16
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS (K083301)Terumo Cardiovascular Systems Corp.2008-12-18
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 (K080034)Terumo Cardiovascular Systems Corp.2008-06-17
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) (K080774)Terumo Cardiovascular Systems Corp.2008-04-17
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521)Terumo Cardiovascular Systems Corp.2007-11-21
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR (K070839)Terumo Cardiovascular Systems Corp.2007-04-24
TENDERFLOW PERIATRIC ARTERIAL CANNULA (K063618)Terumo Cardiovascular Systems Corp.2007-03-13
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA (K062597)Terumo Cardiovascular Systems Corp.2006-11-03
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR (K062381)Terumo Cardiovascular Systems Corp.2006-08-24
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K051997)Terumo Cardiovascular Systems Corp.2005-09-15
CAPIOX AF125X ARTERIAL FILTER (K052205)Terumo Cardiovascular Systems Corp.2005-09-12
CAPIOX FLEXIBLE VENOUS RESERVOIR (K040023)Terumo Cardiovascular Systems Corp.2004-03-01
TERUMO AL8X ARTERIAL FILTER WITH X-COATING (K032128)Terumo Cardiovascular Systems Corp.2003-08-01
VIRTUOSAPH (K031891)Terumo Cardiovascular Systems Corp.2003-07-29
CAPIOX CARDIOTOMY RESERVOIR (K030505)Terumo Cardiovascular Systems Corp.2003-05-14
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947)Terumo Cardiovascular Systems Corp.2003-03-20
CIRCUIT TUBINGS WITH X-COATING (K023056)Terumo Cardiovascular Systems Corp.2002-11-26
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967)Terumo Cardiovascular Systems Corp.2002-06-20
TERUMO GAS FILTER (K021020)Terumo Cardiovascular Systems Corp.2002-06-10
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998)Terumo Cardiovascular Systems Corp.2002-04-04
PUMP TUBING (K013578)Terumo Cardiovascular Systems Corp.2002-01-22
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING (K010443)Terumo Cardiovascular Systems Corp.2001-12-11
CAPIOX RX HARDSHELL RESERVOIR (K013526)Terumo Cardiovascular Systems Corp.2001-11-15
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X (K012209)Terumo Cardiovascular Systems Corp.2001-08-15
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X (K011804)Terumo Cardiovascular Systems Corp.2001-07-09
ADAPTERS WITH X-COATING (K003604)Terumo Cardiovascular Systems Corp.2001-02-07
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING (K002238)Terumo Cardiovascular Systems Corp.2000-08-22

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Every clearance here is in the API, with alerts when new ones post.