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Edwards Lifesciences, LLC

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

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RecordFirmDate
SAPIEN M3 Transcatheter Mitral Valve Replacement System (P250019)Edwards Lifesciences, LLC2025-12-22
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 (P140031/S197)Edwards Lifesciences, LLC2025-12-17
Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI (P150048/S095)Edwards Lifesciences, LLC2025-12-17
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc (P140031/S196)Edwards Lifesciences, LLC2025-12-17
EVOQUE Tricuspid Valve Replacement System (P230013/S019)Edwards Lifesciences, LLC2025-11-19
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S013)Edwards Lifesciences, LLC2025-10-31
TRIFORMIS RESILIA Tricuspid Valve (P150048/S092)Edwards Lifesciences, LLC2025-10-27
Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (P140031/S195)Edwards Lifesciences, LLC2025-10-16
INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (P150048/S093)Edwards Lifesciences, LLC2025-10-16
EDWARDS INTUITY Elite Valve (P150036/S078)Edwards Lifesciences, LLC2025-10-16
Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (P860057/S223)Edwards Lifesciences, LLC2025-10-16
Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S071)Edwards Lifesciences, LLC2025-10-16
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S194)Edwards Lifesciences, LLC2025-10-10
Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P200015/S070)Edwards Lifesciences, LLC2025-10-02
PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S026)Edwards Lifesciences, LLC2025-10-02
Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P140031/S193)Edwards Lifesciences, LLC2025-10-02
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S020)Edwards Lifesciences, LLC2025-09-25
Edwards EVOQUE tricuspid delivery system (P230013/S018)Edwards Lifesciences, LLC2025-09-12
PASCAL Precision Transcatheter Valve Repair System (P220003/S025)Edwards Lifesciences, LLC2025-09-09
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System (P230013/S016)Edwards Lifesciences, LLC2025-08-13
PASCAL Precision Transcatheter Valve Repair System (P220003/S024)Edwards Lifesciences, LLC2025-07-25
Edwards EVOQUE tricuspid delivery system (P230013/S017)Edwards Lifesciences, LLC2025-07-23
PASCAL Precision Transcatheter Valve Repair System (P220003/S023)Edwards Lifesciences, LLC2025-07-11
Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (P200015/S067)Edwards Lifesciences, LLC2025-07-08
Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (P140031/S191)Edwards Lifesciences, LLC2025-07-08
Edwards Commander Delivery System (P200015/S066)Edwards Lifesciences, LLC2025-06-26
Edwards Commander Delivery System (P140031/S190)Edwards Lifesciences, LLC2025-06-26
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S015)Edwards Lifesciences, LLC2025-06-18
EVOQUE Tricuspid Valve Replacement System (P230013/S014)Edwards Lifesciences, LLC2025-06-06
PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S022)Edwards Lifesciences, LLC2025-06-04
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (P200015/S063)Edwards Lifesciences, LLC2025-06-04
Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed (P140031/S186)Edwards Lifesciences, LLC2025-06-04
EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS (P230013/S012)Edwards Lifesciences, LLC2025-06-04
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S188)Edwards Lifesciences, LLC2025-05-20
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S065)Edwards Lifesciences, LLC2025-05-20
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system (P140031/S182)Edwards Lifesciences, LLC2025-04-30
Edwards Commander Delivery System (P200015/S064)Edwards Lifesciences, LLC2025-04-23
Edwards Commander Delivery System (P140031/S187)Edwards Lifesciences, LLC2025-04-23
PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis (P860057/S220)Edwards Lifesciences, LLC2025-04-10
Crimper (P140031/S185)Edwards Lifesciences, LLC2025-03-25
Crimper (P200015/S062)Edwards Lifesciences, LLC2025-03-25
Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S061)Edwards Lifesciences, LLC2025-03-04
KONECT RESILIA Aortic Valved Conduit (P150048/S088)Edwards Lifesciences, LLC2025-03-04
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, SAPIEN 3 Ultra RESILIA Tra (P140031/S183)Edwards Lifesciences, LLC2025-03-04
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048/S089)Edwards Lifesciences, LLC2025-03-03
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S184)Edwards Lifesciences, LLC2025-03-03
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S060)Edwards Lifesciences, LLC2025-02-24
EDWARDS INTUITY Elite Valve System, INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Va (P150048/S087)Edwards Lifesciences, LLC2025-02-20
Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S221)Edwards Lifesciences, LLC2025-02-20
EDWARDS INTUITY Elite Valve System (P150036/S077)Edwards Lifesciences, LLC2025-02-20
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S010)Edwards Lifesciences, LLC2025-02-11
Edwards SAPIEN 3 Ultra™ RESILIA™ Transcatheter Heart Valve (P140031/S181)Edwards Lifesciences, LLC2024-12-03
INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S086)Edwards Lifesciences, LLC2024-12-03
MITRIS RESILIA Mitral Valve (P150048/S085)Edwards Lifesciences, LLC2024-11-25
SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S180)Edwards Lifesciences, LLC2024-11-14
INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve (P150048/S084)Edwards Lifesciences, LLC2024-11-14
KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S083)Edwards Lifesciences, LLC2024-11-07
PASCAL Precision Transcatheter Valve Repair System (P220003/S021)Edwards Lifesciences, LLC2024-11-07
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S179)Edwards Lifesciences, LLC2024-11-07
Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S059)Edwards Lifesciences, LLC2024-11-07
PASCAL Precision Transcatheter Valve Repair System (P220003/S020)Edwards Lifesciences, LLC2024-10-29
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S004)Edwards Lifesciences, LLC2024-10-03
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S082)Edwards Lifesciences, LLC2024-09-12
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S058)Edwards Lifesciences, LLC2024-09-12
EDWARDS INTUITY Elite Valve System (P150036/S076)Edwards Lifesciences, LLC2024-09-12
Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S219)Edwards Lifesciences, LLC2024-09-12
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S178)Edwards Lifesciences, LLC2024-09-12
Edwards Commander Delivery System (P200015/S057)Edwards Lifesciences, LLC2024-09-11
PASCAL Precision Transcatheter Valve Repair System (P220003/S018)Edwards Lifesciences, LLC2024-09-11
Edwards Commander Delivery System (P140031/S177)Edwards Lifesciences, LLC2024-09-11
PASCAL Precision Transcatheter Valve Repair System (P220003/S019)Edwards Lifesciences, LLC2024-09-11
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S009)Edwards Lifesciences, LLC2024-08-30
EVOQUE Tricuspid Valve Replacement System (P230013/S007)Edwards Lifesciences, LLC2024-08-13
Injection Molding Crimper 9600CR Components (P200015/S056)Edwards Lifesciences, LLC2024-08-12
Injection Molding Crimper 9600CR Components (P140031/S176)Edwards Lifesciences, LLC2024-08-12
EVOQUE Tricuspid Valve Replacement System (P230013/S008)Edwards Lifesciences, LLC2024-08-07
Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C (P140031/S175)Edwards Lifesciences, LLC2024-07-30
EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S006)Edwards Lifesciences, LLC2024-07-30
Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S055)Edwards Lifesciences, LLC2024-07-30
PASCAL Precision Implant System, PASCAL Precision Guide Sheath (P220003/S017)Edwards Lifesciences, LLC2024-07-30
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S081)Edwards Lifesciences, LLC2024-07-02
PASCAL Precision Transcatheter Valve Repair System (P220003/S016)Edwards Lifesciences, LLC2024-07-01
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S172)Edwards Lifesciences, LLC2024-06-21
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S005)Edwards Lifesciences, LLC2024-05-23
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S080)Edwards Lifesciences, LLC2024-05-23
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P200015/S054)Edwards Lifesciences, LLC2024-05-23
Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S218)Edwards Lifesciences, LLC2024-05-23
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems (P140031/S162)Edwards Lifesciences, LLC2024-05-23
EDWARDS INTUITY Elite Valve System (P150036/S075)Edwards Lifesciences, LLC2024-05-23
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S174)Edwards Lifesciences, LLC2024-05-23
Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves (P140031/S173)Edwards Lifesciences, LLC2024-05-09
EVOQUE Tricuspid Valve Replacement System (P230013/S003)Edwards Lifesciences, LLC2024-04-24
PASCAL Precision Transcatheter Valve Repair System (P220003/S015)Edwards Lifesciences, LLC2024-04-15
EVOQUE Tricuspid Valve Replacement System (P230013/S002)Edwards Lifesciences, LLC2024-04-04
Edwards SAPIEN 3™ Transcatheter Heart Valve (P200015/S053)Edwards Lifesciences, LLC2024-03-25
EDWARDS INTUITY Elite Valve System (P150036/S074)Edwards Lifesciences, LLC2024-03-25
Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve (P140031/S171)Edwards Lifesciences, LLC2024-03-25
Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S217)Edwards Lifesciences, LLC2024-03-25
EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S001)Edwards Lifesciences, LLC2024-03-15
MITRIS RESILIA Mitral Valve (P150048/S079)Edwards Lifesciences, LLC2024-03-01
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Every clearance here is in the API, with alerts when new ones post.