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Edwards Lifesciences, LLC

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

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RecordFirmDate
CARPENTIER EDWARDS BIOPROSTHESIS (P870056/S012)Edwards Lifesciences, LLC1999-10-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE (P860057/S010)Edwards Lifesciences, LLC1999-04-13
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S009)Edwards Lifesciences, LLC1999-04-13
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S011)Edwards Lifesciences, LLC1999-04-13
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S010)Edwards Lifesciences, LLC1998-10-26
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR (P870077/S008)Edwards Lifesciences, LLC1998-10-26
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE MODELS 2700 AND 2800 (P860057/S009)Edwards Lifesciences, LLC1998-10-26
CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S006)Edwards Lifesciences, LLC1998-08-26
CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S006)Edwards Lifesciences, LLC1998-08-07
CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700 (P860057/S003)Edwards Lifesciences, LLC1996-12-06
CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL) (P870077/S002)Edwards Lifesciences, LLC1996-12-06
CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL) (P870056/S002)Edwards Lifesciences, LLC1996-12-06
CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S003)Edwards Lifesciences, LLC1996-10-17
CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP (P870077/S003)Edwards Lifesciences, LLC1996-10-17
CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S004)Edwards Lifesciences, LLC1996-10-17
CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700 (P860057/S001)Edwards Lifesciences, LLC1996-01-04
LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625) (P870077/S001)Edwards Lifesciences, LLC1993-09-24
STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES (P870038)Edwards Lifesciences, LLC1991-09-27
EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057)Edwards Lifesciences, LLC1991-09-26
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077)Edwards Lifesciences, LLC1991-09-25
CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 (P870056)Edwards Lifesciences, LLC1991-09-25
DUROMEDICS BILEAFLET HEART VALVE (P850006)Edwards Lifesciences, LLC1986-08-29
MODEL 9310 LUNG WATER COMPUTER (P800003/S001)Edwards Lifesciences, LLC1981-06-12
MODEL 9310 LUNG WATER COMPUTER (P800003)Edwards Lifesciences, LLC1980-07-28
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