FDA.reportPublic FDA data

EDWARDS LIFESCIENCES LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20156912015691EDWARDS LIFESCIENCES LLC1Y2026-01-01ONE EDWARDS WAY IRVINE CA US 92614
30085004781713910Edwards Lifesciences LLC1Y2026-01-0112050 Lone Peak Parkway Draper UT US 84020
30154235673015423567Edwards Lifesciences LLC1N2020-04-258760 South Sandy Parkway, Ste. 300 Sandy UT US 84070

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00690103000245SWAN-GANZ TRUE SIZE - TRUE SIZE THERMODILUTION CATHETER+1(800)822-9637tech_support@edwards.com
00690103205084FOGARTY - FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM+1(800)822-9637tech_support@edwards.com
00690103218602SWAN-GANZ TRUE SIZE - TRUE SIZE THERMODILUTION CATHETER+1(800)822-9637tech_support@edwards.com
00690103218626SWAN-GANZ TRUE SIZE - TRUE SIZE CATHETER DOUBLE LUMEN+1(800)822-9637tech_support@edwards.com
00690103218633SWAN-GANZ TRUE SIZE - TRUE SIZE MONITORING CATHETER TRIPLE LUMEN+1(800)822-9637tech_support@edwards.com
00690103219500Edwards Reusable Rail - 10500RL+1(800)822-9637tech_support@edwards.com
00690103221664PASCAL Ace with Capture Clarity Valve Repair System - PASCAL ACE WITH CAPTURE CLARITY - MR IMPLANT SYSTEM+1(800)822-9637tech_support@edwards.com
00690103222388PASCAL Precision - Edwards PASCAL Precision Transcatheter Valve Repair System - Guide Sheath+1(800)822-9637tech_support@edwards.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
573211625333749P870077CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESISDYE1991-09-25
573211797178365P870056CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625DYE1991-09-25
573211251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1178531617674250P250019SAPIEN M3 Transcatheter Mitral Valve Replacement SystemNPU2025-12-22
573211617674250P250019SAPIEN M3 Transcatheter Mitral Valve Replacement SystemNPU2025-12-22
573211063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
1178531063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
573211875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
1178531875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
573211675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
1178531675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
573211356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
573211430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1178531430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
573211156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1178531156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
2283061156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1178531890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
573211890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
2283061890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
573211446461453P010041CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)DYE2002-06-24
573211598766427P000007EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500PDYE2001-02-27
1178531713104232K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPDWF2000-05-05
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
1178531775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
573211775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
2283061775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
1178532009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
573212009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
2283062009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
1178531209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
573211209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
2283061209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
1178531552943068K964248HEARTPORT ENDOCORONARY SINUS CATHETRDWF1997-01-22
1178531498641641K964161HEARTPORT ENDOAORTIC CLAMPDXC1997-04-04
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
573211024941791K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORDYG1997-05-06
1178531656639928K955132HEARTPORT ENDOAORTIC CLAMPDXC1996-06-07
573211399888722K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
573212054736679K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573211780527625K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573211058000586K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
573211844867035K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573211268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
1178531268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
2283061268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
573211749391495K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
573211701752321K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
573211496814428K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573211565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178531565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
2283061565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178532000045439K922083RMI SURGICCAL SITE VISUALIZATION WANDFQH1993-01-29
573211442415178K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
573211916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
1178531916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
2283061916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
573212020325373K911051MONARCH SYSTEMMHX1991-08-22
1178531307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
573211307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
2283061307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
573211923877145K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573211116041552K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
573211611482014K905458SWAN-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
573212023807060K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
1178531772485555K901231RMI CARDIOPLEGIA DELIVERY KITSDWF1990-06-08
573211200607658K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
1178531727527985K896778RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVEDWF1990-02-27
1178531999468098K896777RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINEDWF1990-02-27
573211196364771K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
1178531513710871K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
573211513710871K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
2283061513710871K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
573211858460119K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
1178531418515405K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SETDTL1989-12-07
573211576100425K884329SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTERDQA1988-12-16
573211865666281K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2DXG1987-09-15
573211698557804K864330SHEAR FORCE GAUGEDXE1987-01-06
1178531601783276K861790RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNTDWF1986-07-21
1178531555903313K861322RMI POROUS VENT PLUGDWF1986-05-30
573211555903313K861322RMI POROUS VENT PLUGDWF1986-05-30
1178531630561882K860988RMI CAROTID BY-PASS SHUNTDWF1986-05-21
1178531235482974K860497CAROTID BALLOON SHUNTDWF1986-05-28
1178531887534648K852456FAP-CATHDQO1985-11-01
573211172398633K842105RIGHT VENTRICULAR EJECTION FRACTION-DXG1985-01-15
573211349899943K833997CO-SET1984-04-17
573211102153579K833763PERICARDIAL PATCHDXZ1984-11-01
573211308823316K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
1178531366433703K831759INTRACARDIA SUCKERSDWF1983-08-12
573211930792010K822723SWAN-GANZ BIPOLAR PACING CATHETERDYG1982-10-15
573211833494736K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATHDYG1982-08-24
573211994614558K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRS1982-07-02
573211659232841K820222SWAN-GANZ VIP-CATHETERDYG1982-02-12
573211804163881K813521TRANSLUMINAL BIPOLAR PACING PROBELDF1982-03-15
573211053030216K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.DYG1981-09-25
573211450579396K811411SWAN-GANZ HEPARIN COATED, ETC. CATHETERKRB1981-06-12
573211959202300K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEMKRB1981-06-09
573211167025030K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTIONDYG1981-03-27
573211926015187K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
573211547524568K810124SWAN-GANZ VIP THERMODILUTION CATHETERDYG1981-02-04
573211461476754K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.LDF1981-01-16
573211934978439K791183SWAN-GANZ FLOW-DIRECTED CATHETERLDF1979-07-12
573212039664140K790047CARDIAC OUTPUT COMPUTER, MDEL 9520ADXG1979-02-26
1178531674196197K254279Edwards eSheath+ introducer setDYB2026-04-17
573211674196197K254279Edwards eSheath+ introducer setDYB2026-04-17
573211941802400K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)PZX2026-06-26
573211842429779K253186HemoSphere Nano Monitor (HSNANO1)DQK2026-02-24
573211831751131K253034HemoSphere Stream ModuleDQK2025-10-21
573211286331585K252364Edwards eSheath Optima introducer setDYB2025-08-29
573211794933339K251982Edwards MC3 Tricuspid annuloplasty ring (4900)KRH2025-09-23
573211623759230K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH2025-09-17
573211353810171K244046Edwards eSheath Optima introducer setDYB2025-03-27
573211731321500K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)DQK2025-07-23
573211771138434K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS2025-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF552020-03-29
KRH252025-09-23
DYB202026-04-17
DYG202024-12-09
DQK172026-02-24
DXC152017-01-26
DXG112014-05-22
MUD92024-10-16
DXE92024-08-28
DQE82018-02-20
DXO72022-12-22
DQR72008-01-31
KRA62018-11-08
NPT62015-06-17
DXN52023-10-24
OZT52014-10-29
DQO52011-02-11
DRS42025-03-21
LDF42015-10-15
QAQ32023-06-08
LWR32017-06-29
OMZ32016-01-07
MJN32015-11-23
KRB32010-12-07
DRE32010-04-13
DTM32006-09-27
NKM 22022-09-14
NPV 22020-08-31
DTL22012-01-12
DXZ22008-10-23
PZX12026-06-26
QMS12024-08-02
QNL12023-07-26
DXF12022-08-22
PSQ12017-11-17
FOZ12003-12-30
DQY12003-10-02
MCW11995-02-07
FQH11993-01-29
DYE11991-09-26

PMN#

GUDID#

200 records. Showing 1-40. Next