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Edwards Lifesciences, LLC

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

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RecordFirmDate
RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO (P110021/S013)Edwards Lifesciences, LLC2013-05-22
RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER (P100041/S027)Edwards Lifesciences, LLC2013-05-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S023)Edwards Lifesciences, LLC2013-04-24
DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S053)Edwards Lifesciences, LLC2013-04-24
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S042)Edwards Lifesciences, LLC2013-04-24
PORCINE AORTIC BIOPROTHESIS AND PORCINE MITRAL BIOPROSTHESIS (P870056/S058)Edwards Lifesciences, LLC2013-04-24
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S107)Edwards Lifesciences, LLC2013-04-24
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S040)Edwards Lifesciences, LLC2013-04-24
TRANSCATHETER HEART VALVE (P110021/S009)Edwards Lifesciences, LLC2013-04-24
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S010)Edwards Lifesciences, LLC2013-04-18
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S024)Edwards Lifesciences, LLC2013-04-18
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS (P860057/S106)Edwards Lifesciences, LLC2013-04-16
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S057)Edwards Lifesciences, LLC2013-03-12
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S008)Edwards Lifesciences, LLC2013-03-12
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S039)Edwards Lifesciences, LLC2013-03-12
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S041)Edwards Lifesciences, LLC2013-03-12
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS (P870077/S052)Edwards Lifesciences, LLC2013-03-12
CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES (P860057/S105)Edwards Lifesciences, LLC2013-03-12
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S022)Edwards Lifesciences, LLC2013-03-12
CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDSPERIMOUNT THEON PERCARDIAL AORTIC BIOPRO (P860057/S104)Edwards Lifesciences, LLC2013-03-12
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS (P870056/S055)Edwards Lifesciences, LLC2013-02-28
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S037)Edwards Lifesciences, LLC2013-02-28
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW (P100041/S018)Edwards Lifesciences, LLC2013-02-28
CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS (P010041/S039)Edwards Lifesciences, LLC2013-02-28
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE (P870077/S050)Edwards Lifesciences, LLC2013-02-28
CARPENTIER-EDWARDS PERIMOUNT FAMILY OF PERICARDIAL BIOPROSTHESES (P860057/S098)Edwards Lifesciences, LLC2013-02-28
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWAR (P110021/S003)Edwards Lifesciences, LLC2013-02-28
PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S103)Edwards Lifesciences, LLC2013-02-14
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S007)Edwards Lifesciences, LLC2013-02-08
SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S021)Edwards Lifesciences, LLC2013-02-08
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S006)Edwards Lifesciences, LLC2013-01-30
CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS (P860057/S102)Edwards Lifesciences, LLC2013-01-30
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S020)Edwards Lifesciences, LLC2013-01-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S101)Edwards Lifesciences, LLC2013-01-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S099)Edwards Lifesciences, LLC2012-12-28
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S049)Edwards Lifesciences, LLC2012-12-11
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S038)Edwards Lifesciences, LLC2012-12-11
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER (P110021/S002)Edwards Lifesciences, LLC2012-12-11
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S054)Edwards Lifesciences, LLC2012-12-11
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS (P100041/S017)Edwards Lifesciences, LLC2012-12-11
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMAFIX (P860057/S097)Edwards Lifesciences, LLC2012-12-11
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S036)Edwards Lifesciences, LLC2012-12-11
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S016)Edwards Lifesciences, LLC2012-12-10
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S037)Edwards Lifesciences, LLC2012-12-10
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S048)Edwards Lifesciences, LLC2012-12-10
CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES (P870056/S053)Edwards Lifesciences, LLC2012-12-10
VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS (P860057/S096)Edwards Lifesciences, LLC2012-12-10
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S001)Edwards Lifesciences, LLC2012-12-10
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S035)Edwards Lifesciences, LLC2012-12-10
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES (P860057/S095)Edwards Lifesciences, LLC2012-11-26
CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S094)Edwards Lifesciences, LLC2012-11-20
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S015)Edwards Lifesciences, LLC2012-11-13
CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S093)Edwards Lifesciences, LLC2012-11-13
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S011)Edwards Lifesciences, LLC2012-11-06
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021)Edwards Lifesciences, LLC2012-10-19
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S092)Edwards Lifesciences, LLC2012-10-04
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S047)Edwards Lifesciences, LLC2012-10-04
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S034)Edwards Lifesciences, LLC2012-10-04
CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS (P870056/S052)Edwards Lifesciences, LLC2012-10-04
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S036)Edwards Lifesciences, LLC2012-10-04
CAPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P870077/S046)Edwards Lifesciences, LLC2012-09-19
CAPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S091)Edwards Lifesciences, LLC2012-09-19
CARPENTIER-EDWARDS S.A.V. NIOPROSTHESIS (P010041/S035)Edwards Lifesciences, LLC2012-09-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S033)Edwards Lifesciences, LLC2012-09-19
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S014)Edwards Lifesciences, LLC2012-09-19
CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS (P870056/S051)Edwards Lifesciences, LLC2012-09-19
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S008)Edwards Lifesciences, LLC2012-08-20
EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV) (P100041/S013)Edwards Lifesciences, LLC2012-08-09
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S012)Edwards Lifesciences, LLC2012-07-11
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S050)Edwards Lifesciences, LLC2012-07-11
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSHESIS (P860057/S090)Edwards Lifesciences, LLC2012-07-11
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S045)Edwards Lifesciences, LLC2012-07-11
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S032)Edwards Lifesciences, LLC2012-07-11
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S034)Edwards Lifesciences, LLC2012-07-11
S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC) (P010041/S030)Edwards Lifesciences, LLC2012-06-26
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S089)Edwards Lifesciences, LLC2012-05-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870056/S049)Edwards Lifesciences, LLC2012-05-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P010041/S033)Edwards Lifesciences, LLC2012-05-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P000007/S031)Edwards Lifesciences, LLC2012-05-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870077/S044)Edwards Lifesciences, LLC2012-05-30
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S010)Edwards Lifesciences, LLC2012-05-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX (P860057/S088)Edwards Lifesciences, LLC2012-05-15
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) (P100041/S009)Edwards Lifesciences, LLC2012-05-09
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S030)Edwards Lifesciences, LLC2012-04-13
CARPENTIER-EDWARDS® SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S032)Edwards Lifesciences, LLC2012-04-13
CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES (P870077/S043)Edwards Lifesciences, LLC2012-04-13
CARPENTIER-EDWARDS® PORCINE BIOPROSTHESIS (P870056/S048)Edwards Lifesciences, LLC2012-04-13
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S087)Edwards Lifesciences, LLC2012-04-13
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S002)Edwards Lifesciences, LLC2012-04-06
CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300 (P870056/S047)Edwards Lifesciences, LLC2012-04-04
CARPENTIER-EDWARDS BIOPROSTHESIS MODEL 2625 AND 6625 (P870056/S046)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S086)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP (P870077/S042)Edwards Lifesciences, LLC2012-03-22
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S029)Edwards Lifesciences, LLC2012-03-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S007)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS SUPRAANULAR BIOPROSTHESIS MODEL 2650 (P010041/S031)Edwards Lifesciences, LLC2012-03-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM (P100041/S006)Edwards Lifesciences, LLC2012-03-20
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS, 3000/3000TFX AND 3300TFX (P860057/S085)Edwards Lifesciences, LLC2012-02-24
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S005)Edwards Lifesciences, LLC2012-02-17
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S001)Edwards Lifesciences, LLC2012-01-31
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Every clearance here is in the API, with alerts when new ones post.