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Edwards Lifesciences, LLC

1,178 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S003)Edwards Lifesciences, LLC2012-01-19
CARPENTIER-EDWARDS DURAFLEX LOW PRESSUR MITRAL BIOPROSTHESIS (P870077/S041)Edwards Lifesciences, LLC2012-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S028)Edwards Lifesciences, LLC2012-01-19
CARPENTIER-EDWARDS BIOPROSTHESES (P870056/S045)Edwards Lifesciences, LLC2012-01-19
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S082)Edwards Lifesciences, LLC2012-01-19
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S029)Edwards Lifesciences, LLC2012-01-19
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S004)Edwards Lifesciences, LLC2012-01-18
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S083)Edwards Lifesciences, LLC2012-01-18
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S040)Edwards Lifesciences, LLC2011-12-12
EDWARDS PRIMA PLUS PROCINE STENTLESS BIOPROSTHESTIC VALVES (P010041/S028)Edwards Lifesciences, LLC2011-12-12
EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S027)Edwards Lifesciences, LLC2011-12-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIV VALVES (P860057/S081)Edwards Lifesciences, LLC2011-12-12
CAPENTIER-EDWARDS PORCINE BIOPRSTHETIC (P870056/S044)Edwards Lifesciences, LLC2011-12-12
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041)Edwards Lifesciences, LLC2011-11-02
PERIMOUNT BIOPROSTHESES (P860057/S079)Edwards Lifesciences, LLC2011-09-21
CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES (P870056/S040)Edwards Lifesciences, LLC2011-07-27
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES (P860057/S072)Edwards Lifesciences, LLC2011-07-27
EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S025)Edwards Lifesciences, LLC2011-07-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX (P860057/S071)Edwards Lifesciences, LLC2011-07-26
CARPENTIER-EDWARDS PORCINE AORTIC/PORCINE MITRAL BIOPROSTHESIS (P870056/S043)Edwards Lifesciences, LLC2011-05-05
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S027)Edwards Lifesciences, LLC2011-05-05
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S039)Edwards Lifesciences, LLC2011-05-05
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS (P860057/S078)Edwards Lifesciences, LLC2011-05-05
GLUTARALDEHYDE SOLUTION SYSTEM (P860057/S076)Edwards Lifesciences, LLC2011-03-03
CARPENTIER EDWARDS PROCINE BIOPROSTHESIS (P870056/S042)Edwards Lifesciences, LLC2011-01-20
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S026)Edwards Lifesciences, LLC2011-01-20
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S075)Edwards Lifesciences, LLC2011-01-20
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S038)Edwards Lifesciences, LLC2011-01-20
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S074)Edwards Lifesciences, LLC2010-12-23
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S037)Edwards Lifesciences, LLC2010-12-22
EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S026)Edwards Lifesciences, LLC2010-12-22
CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES (P870056/S041)Edwards Lifesciences, LLC2010-12-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES (P860057/S073)Edwards Lifesciences, LLC2010-12-22
EDWARDS PRIMA PLUS PORCINE STENTLESS BIOPROSTHETIC VALVES (P010041/S025)Edwards Lifesciences, LLC2010-12-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S070)Edwards Lifesciences, LLC2010-10-27
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S069)Edwards Lifesciences, LLC2010-07-09
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX (P860057/S068)Edwards Lifesciences, LLC2010-06-24
CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE (P860057/S063)Edwards Lifesciences, LLC2010-03-25
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX AND MODELS 7200TFX (P860057/S065)Edwards Lifesciences, LLC2010-03-05
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS MODELS 2700/TFX/2800/TFX/3000/TFX/3300TFX/6900/P/PTFX/7000/TFX (P860057/S067)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S039)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S024)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP (P870077/S036)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX (P860057/S066)Edwards Lifesciences, LLC2010-02-18
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS MODELS 6625L/6625-ESR-LP (P870077/S035)Edwards Lifesciences, LLC2010-02-18
CARPENTIER EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S038)Edwards Lifesciences, LLC2010-02-18
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S024)Edwards Lifesciences, LLC2010-02-18
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS MODEL 2650 (P010041/S023)Edwards Lifesciences, LLC2010-02-18
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S022)Edwards Lifesciences, LLC2010-01-14
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S023)Edwards Lifesciences, LLC2010-01-14
CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S037)Edwards Lifesciences, LLC2010-01-14
CARPENTIER EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S034)Edwards Lifesciences, LLC2010-01-14
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S064)Edwards Lifesciences, LLC2010-01-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S062)Edwards Lifesciences, LLC2010-01-05
CARPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S036)Edwards Lifesciences, LLC2009-12-30
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S033)Edwards Lifesciences, LLC2009-12-30
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S021)Edwards Lifesciences, LLC2009-12-30
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S022)Edwards Lifesciences, LLC2009-12-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES HEART VALVES (P860057/S055)Edwards Lifesciences, LLC2009-12-11
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S053)Edwards Lifesciences, LLC2009-12-08
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S035)Edwards Lifesciences, LLC2009-11-25
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S021)Edwards Lifesciences, LLC2009-11-25
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S020)Edwards Lifesciences, LLC2009-11-25
CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S061)Edwards Lifesciences, LLC2009-11-25
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S032)Edwards Lifesciences, LLC2009-11-25
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S060)Edwards Lifesciences, LLC2009-11-06
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S057)Edwards Lifesciences, LLC2009-11-03
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S059)Edwards Lifesciences, LLC2009-09-18
CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S034)Edwards Lifesciences, LLC2009-07-23
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S058)Edwards Lifesciences, LLC2009-07-21
CARPENTIER-EDWARDS BIOPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S033)Edwards Lifesciences, LLC2009-07-09
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS (P860057/S056)Edwards Lifesciences, LLC2009-07-09
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S042)Edwards Lifesciences, LLC2009-05-07
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX (P860057/S054)Edwards Lifesciences, LLC2009-02-20
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX (P860057/S051)Edwards Lifesciences, LLC2009-01-27
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S026)Edwards Lifesciences, LLC2009-01-23
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S019)Edwards Lifesciences, LLC2008-12-31
CAEPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S032)Edwards Lifesciences, LLC2008-12-31
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S020)Edwards Lifesciences, LLC2008-12-31
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S031)Edwards Lifesciences, LLC2008-12-31
CARPENTIER-EDWARDS BIOPROSTHESIS & BIOPROSTHETIC VALVED CONDUIT (P870056/S031)Edwards Lifesciences, LLC2008-12-17
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S030)Edwards Lifesciences, LLC2008-12-17
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S052)Edwards Lifesciences, LLC2008-12-17
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S018)Edwards Lifesciences, LLC2008-12-17
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S019)Edwards Lifesciences, LLC2008-12-17
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S014)Edwards Lifesciences, LLC2008-12-12
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S029)Edwards Lifesciences, LLC2008-10-29
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S017)Edwards Lifesciences, LLC2008-10-29
CARPENTIER-EDWARDS VALVED CONDUIT BIOPROSTHESIS (P870056/S030)Edwards Lifesciences, LLC2008-10-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S050)Edwards Lifesciences, LLC2008-10-29
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S018)Edwards Lifesciences, LLC2008-10-29
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX (P860057/S029)Edwards Lifesciences, LLC2008-08-29
CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S016)Edwards Lifesciences, LLC2008-07-10
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S017)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S048)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S028)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S029)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 AND 2800TFX (P860057/S047)Edwards Lifesciences, LLC2008-07-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL (P860057/S046)Edwards Lifesciences, LLC2008-06-06
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S015)Edwards Lifesciences, LLC2008-05-23
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Every clearance here is in the API, with alerts when new ones post.