FDA.report

EDWARDS LIFESCIENCES LLC

Matched from indexed company URL: EDWARDS LIFESCIENCES

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
20156912015691EDWARDS LIFESCIENCES LLC1Y2026-01-01ONE EDWARDS WAY IRVINE CA US 92614
26480452648045EDWARDS LIFESCIENCES TECHNOLOGY SARL1N2026-01-01STATE ROAD 402, KM 1.4, Industrial Park ANASCO PR US 00610
30070632183007063218EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd1N2026-01-0135 Changi North Crescent Changi South East SG 499641
30085004781713910Edwards Lifesciences LLC1Y2026-01-0112050 Lone Peak Parkway Draper UT US 84020
30151793943015179394Edwards Lifesciences LTD1N2026-01-0110 Earhart Ave Shannon Industrial Estates Shannon Clare IE V14 P638
26480452648045EDWARDS LIFESCIENCES TECHNOLOGY SARL1N2020-04-25STATE ROAD 402, KM 1.4, Industrial Park ANASCO PR US 00610
30154235673015423567Edwards Lifesciences LLC1N2020-04-258760 South Sandy Parkway, Ste. 300 Sandy UT US 84070

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
573201849337975P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911AHQL2001-04-05
573201628108765P980040SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSHQL2000-02-03
573201017573804P880081UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSESHQL1989-10-31
573211625333749P8700771969-12-31
573211797178365P870056CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625DYE 1991-09-25
573211251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1100901251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1178531617674250P2500191969-12-31
573211617674250P2500191969-12-31
1178531063643663P2300131969-12-31
1100901063643663P2300131969-12-31
573211063643663P2300131969-12-31
1178531875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM 2022-09-14
1100901875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM 2022-09-14
573211875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM 2022-09-14
1178531675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV 2020-08-31
1100901675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV 2020-08-31
573211675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV 2020-08-31
1100901356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
573211356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
1178531430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1100901430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
573211430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
2283061156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1178531156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1100901156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
573211156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
573211890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
1100901890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
1178531890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
2283061890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
573211446461453P0100411969-12-31
573211598766427P0000071969-12-31
1178531713104232K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPDWF2000-05-05
573201312188332K992532VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATINGFOZ2000-06-13
1178532066842590K990396T-ANASTAFLODWF1999-10-01
573211003852338K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SBMJN1999-07-30
573201235752861K981909BAXTER HEMOSTASIS VALVE INTRODUCERSDYB1998-11-24
2283061775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
1178531775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
573211775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
573201035020585K973195TOTAL PERFORMANCE SYSTEM SHAVERHRX1997-10-24
573201882579785K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
2283062009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
1178532009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
573212009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
573201737853004K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACKFQH1997-07-29
2283061209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
1178531209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
573211209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
573201012825011K970714STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)CAC1997-12-16
1178531552943068K964248HEARTPORT ENDOCORONARY SINUS CATHETRDWF1997-01-22
1178531498641641K964161HEARTPORT ENDOAORTIC CLAMPDXC1997-04-04
573201318945094K963765STRYKER STRYKEFLOW ELECTROCAUTERY PROBESGEI1997-01-31
573201679443514K963648STRYKER SUCTION REGULATORGCX1996-11-26
1178532070255829K962858HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEMDXC1996-09-30
1178531569509058K962510HEARTPORT ENDOAORTIC CLAMPDXC1996-09-11
1178531627486625K960098RMI INTERNAL MAMMARY ARTERY CANNULADQR1996-03-26
573201043322331K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1996-03-25
573211024941791K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORDYG1997-05-06
1178531656639928K955132HEARTPORT ENDOAORTIC CLAMPDXC1996-06-07
573201156082955K952681STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1995-07-20
573201798873801K952038CLEAN-CUFFKCY1995-07-11
573211399888722K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
573201399888722K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
3477091402540327K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
573201877961121K943569STRYKER TOTAL PERFORMANCE SYSTEMERL1995-01-09
3477091849442333K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573212054736679K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573202054736679K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573201412020774K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
3477091230174822K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573211780527625K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573201780527625K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573211058000586K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
573201058000586K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
3477091276395751K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
573201585844414K931847BIO-PREP CEMENT RESTRICTORLZN1994-06-28
3477091802546451K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573211844867035K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573201844867035K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
2283061268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
1178531268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
573211268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
573211749391495K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
573211701752321K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
573201701752321K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091760674244K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091113427413K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573211496814428K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573201496814428K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
2283061565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178531565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
573211565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178532000045439K922083RMI SURGICCAL SITE VISUALIZATION WANDFQH1993-01-29
573211442415178K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
573201442415178K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
3477092073667714K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
2283061916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
1178531916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
573211916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
573212020325373K911051MONARCH SYSTEMMHX1991-08-22
573211307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
1178531307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
2283061307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
3477091097746347K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573211923877145K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573201923877145K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573211116041552K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
573201116041552K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091748949150K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091177215850K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
573211611482014K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
573201611482014K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
1178531332004087K905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELSDWF1991-01-15
1178531868364932K905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.DWD1991-01-15
573211437359262K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
573201437359262K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477092031753840K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477091584598161K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DWF552020-03-29
DYG522024-12-09
DYB262026-04-17
KRH252025-09-23
DQE232018-02-20
DXE212024-08-28
DXC192017-01-26
DQK182026-02-24
LDF122015-10-15
DXG112014-05-22
DQO112011-02-11
MUD92024-10-16
DXO92022-12-22
KRA82018-11-08
NPT82015-06-17
MJN72015-11-23
FOZ72012-05-18
KRB72010-12-07
DQR72008-01-31
DRS62025-03-21
DXN52023-10-24
LWR52017-06-29
OZT52014-10-29
MBI42012-07-26
GEI42007-09-20
ERL42004-03-03
DQY42003-10-02
QAQ32023-06-08
NKM 32022-09-14
NPV 32020-08-31
OMZ32016-01-07
DRE32010-04-13
HIF32007-05-23
DTM32006-09-27
HQL32001-04-05
FQH31997-07-29
MCW31995-02-07
FGE31991-02-13
DTL22012-01-12
DXZ22008-10-23

PMA

Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

2023-01-20

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS151 Date Received01/05/2023 Decision Date01/20/2023 Product Code NPT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement ...

PASCAL Precision Transcatheter Valve Repair System

2022-12-20

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS005 Date Received12/19/2022 Decision Date12/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

Crimper

2022-12-12

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS150 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Crimper

2022-12-12

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS032 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

PASCAL Precision Transcatheter Valve Repair System

2022-12-07

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS004 Date Received11/15/2022 Decision Date12/07/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

PASCAL Precision Transcatheter Valve Repair System

2022-12-07

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

PASCAL Precision Transcatheter Valve Repair System

2022-11-20

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

2022-11-16

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS149 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

2022-11-16

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS031 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Edwards Certitude Introducer Sheath Set

2022-10-26

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS147 Date Received09/26/2022 Decision Date10/26/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards Commander Delivery System

2022-10-24

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS148 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards Commander Delivery System

2022-10-24

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS030 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

EDWARDS INTUITY Elite Valve System

2022-10-19

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS065 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards SAPIEN 3™ Transcatheter Heart Valve

2022-09-23

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS027 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

EDWARDS INTUITY Elite Valve System

2022-09-23

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS064 Date Received08/25/2022 Decision Date09/23/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

PMN

Applications

GUDID

TRUWAVE

2026-03-20

Edwards Lifesciences LLC

TRUWAVE

2026-03-20

Edwards Lifesciences LLC