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Edwards Lifesciences, LLC

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

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RecordFirmDate
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (P010041/S015)Edwards Lifesciences, LLC2008-05-23
CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S045)Edwards Lifesciences, LLC2008-05-23
CARPENTIER-EDWARDS PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS (P870056/S028)Edwards Lifesciences, LLC2008-05-23
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP (P870077/S027)Edwards Lifesciences, LLC2008-05-23
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S016)Edwards Lifesciences, LLC2008-05-22
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S025)Edwards Lifesciences, LLC2007-12-13
CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S014)Edwards Lifesciences, LLC2007-12-13
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S027)Edwards Lifesciences, LLC2007-12-13
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S013)Edwards Lifesciences, LLC2007-12-13
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S044)Edwards Lifesciences, LLC2007-12-13
CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX (P860057/S041)Edwards Lifesciences, LLC2007-02-13
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL) (P860057/S037)Edwards Lifesciences, LLC2007-02-08
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROTHESIS (P870077/S022)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S038)Edwards Lifesciences, LLC2007-01-29
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S011)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S011)Edwards Lifesciences, LLC2007-01-29
STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S009)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S024)Edwards Lifesciences, LLC2007-01-29
STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120 (P870038/S011)Edwards Lifesciences, LLC2007-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S012)Edwards Lifesciences, LLC2007-01-18
BIOPROSTHESIS MODEL 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S025)Edwards Lifesciences, LLC2007-01-18
PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S039)Edwards Lifesciences, LLC2007-01-18
SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODELS 2650,6650 (P010041/S012)Edwards Lifesciences, LLC2007-01-18
DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S023)Edwards Lifesciences, LLC2007-01-18
SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S010)Edwards Lifesciences, LLC2007-01-18
PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES (P860057/S036)Edwards Lifesciences, LLC2007-01-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX (P860057/S040)Edwards Lifesciences, LLC2006-11-08
STARR EDWARDS SILASTIC BALL PROSTHESIS MODELS 1260 & 6120 (P870038/S008)Edwards Lifesciences, LLC2006-09-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 & 2800TFX (P860057/S035)Edwards Lifesciences, LLC2006-07-18
CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL 6900PTFX (P860057/S033)Edwards Lifesciences, LLC2006-05-18
CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S034)Edwards Lifesciences, LLC2006-05-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPORSTHESIS MODELS 2700TFX, 2800TFX,3000TFX AND 6900PTFX (P860057/S032)Edwards Lifesciences, LLC2006-03-24
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V) BIOPROSTHESIS,MODEL 2650 (P010041/S010)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S021)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625 (P870056/S023)Edwards Lifesciences, LLC2005-12-06
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P (P000007/S010)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S031)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S020)Edwards Lifesciences, LLC2005-10-07
EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P (P000007/S009)Edwards Lifesciences, LLC2005-10-07
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S009)Edwards Lifesciences, LLC2005-10-07
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 (P870056/S022)Edwards Lifesciences, LLC2005-10-07
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P (P860057/S030)Edwards Lifesciences, LLC2005-10-07
STARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120 (P870038/S007)Edwards Lifesciences, LLC2005-09-13
STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120 (P870038/S005)Edwards Lifesciences, LLC2005-07-20
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X (P860057/S028)Edwards Lifesciences, LLC2005-05-20
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500, 2500P (P000007/S008)Edwards Lifesciences, LLC2005-05-20
CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650 (P010041/S008)Edwards Lifesciences, LLC2005-05-20
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S019)Edwards Lifesciences, LLC2005-05-20
CARPENTIER-EDWARDS BIOPRSOTHESIS, MODEL 2625,6625 (P870056/S021)Edwards Lifesciences, LLC2005-05-20
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP (P870077/S018)Edwards Lifesciences, LLC2005-04-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN (P860057/S027)Edwards Lifesciences, LLC2005-04-08
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S007)Edwards Lifesciences, LLC2005-04-08
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S007)Edwards Lifesciences, LLC2005-04-08
CARPENTIER-EDWARDS BIOPROSTHESIS MODELS 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S020)Edwards Lifesciences, LLC2005-04-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX (P860057/S023)Edwards Lifesciences, LLC2005-04-07
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP (P870077/S017)Edwards Lifesciences, LLC2005-02-28
CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL 2625, 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S019)Edwards Lifesciences, LLC2005-02-28
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700, 2700TFX 2800TFX (P860057/S026)Edwards Lifesciences, LLC2005-02-28
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S006)Edwards Lifesciences, LLC2005-02-28
CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S006)Edwards Lifesciences, LLC2005-02-28
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S018)Edwards Lifesciences, LLC2005-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S005)Edwards Lifesciences, LLC2005-01-19
CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650 (P010041/S005)Edwards Lifesciences, LLC2005-01-19
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP (P870077/S016)Edwards Lifesciences, LLC2005-01-19
PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX (P860057/S025)Edwards Lifesciences, LLC2005-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S004)Edwards Lifesciences, LLC2004-12-29
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S015)Edwards Lifesciences, LLC2004-12-29
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S004)Edwards Lifesciences, LLC2004-12-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS, MODELS 2700, 2700TFX, 2800,2800TFX, 3000, 3000TFX,6900P (PERI... (P860057/S024)Edwards Lifesciences, LLC2004-12-29
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S017)Edwards Lifesciences, LLC2004-12-29
PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000 (P860057/S022)Edwards Lifesciences, LLC2004-01-26
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC (P860057/S018)Edwards Lifesciences, LLC2003-11-14
CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND (P870056/S015)Edwards Lifesciences, LLC2003-08-22
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S003)Edwards Lifesciences, LLC2003-05-09
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S013)Edwards Lifesciences, LLC2003-05-09
CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS (P010041/S002)Edwards Lifesciences, LLC2003-05-09
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S019)Edwards Lifesciences, LLC2003-05-09
PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS,MODEL 6900P,MITRAL (P860057/S021)Edwards Lifesciences, LLC2003-04-18
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S001)Edwards Lifesciences, LLC2003-01-17
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S014)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S003)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S020)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S016)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) (P010041)Edwards Lifesciences, LLC2002-06-24
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S002)Edwards Lifesciences, LLC2002-03-26
PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S001)Edwards Lifesciences, LLC2002-02-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S016)Edwards Lifesciences, LLC2001-11-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 6900 MITRAL (P860057/S015)Edwards Lifesciences, LLC2001-05-15
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S017)Edwards Lifesciences, LLC2001-05-15
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007)Edwards Lifesciences, LLC2001-02-27
STARR EDWARDS SILASTIC BALL VALVE (P870038/S004)Edwards Lifesciences, LLC2001-01-05
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S011)Edwards Lifesciences, LLC2000-08-28
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S012)Edwards Lifesciences, LLC2000-08-04
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE (P860057/S014)Edwards Lifesciences, LLC2000-08-04
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S014)Edwards Lifesciences, LLC2000-08-04
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE, MODELS 2700 AND 2800 (P860057/S013)Edwards Lifesciences, LLC2000-06-16
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS, MODELS 6625LP/ESR (P870077/S011)Edwards Lifesciences, LLC2000-06-16
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S013)Edwards Lifesciences, LLC2000-06-16
CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S010)Edwards Lifesciences, LLC1999-10-22
CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S012)Edwards Lifesciences, LLC1999-10-22
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