FDA.reportPublic FDA data

EDWARDS LIFESCIENCES TECHNOLOGY SARL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26480452648045EDWARDS LIFESCIENCES TECHNOLOGY SARL1N2026-01-01STATE ROAD 402, KM 1.4, Industrial Park ANASCO PR US 00610
26480452648045EDWARDS LIFESCIENCES TECHNOLOGY SARL1N2020-04-25STATE ROAD 402, KM 1.4, Industrial Park ANASCO PR US 00610

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
573201312188332K992532VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATINGFOZ2000-06-13
3477091806729782K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578JKA1999-07-28
573201235752861K981909BAXTER HEMOSTASIS VALVE INTRODUCERSDYB1998-11-24
573201035020585K973195TOTAL PERFORMANCE SYSTEM SHAVERHRX1997-10-24
573201882579785K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
573201737853004K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACKFQH1997-07-29
573201012825011K970714STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)CAC1997-12-16
573201318945094K963765STRYKER STRYKEFLOW ELECTROCAUTERY PROBESGEI1997-01-31
573201679443514K963648STRYKER SUCTION REGULATORGCX1996-11-26
573201043322331K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1996-03-25
573201156082955K952681STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1995-07-20
573201798873801K952038CLEAN-CUFFKCY1995-07-11
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
573202054736679K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573201412020774K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
3477091695833343K940905MICROTAINER BRAND TUBE WITH EDTA(K2)JKA1994-08-02
3477091230174822K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573201780527625K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
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
573201844867035K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573201701752321K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091760674244K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091113427413K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573201496814428K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573201442415178K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
3477092073667714K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
3477091097746347K910204SWAN-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
573201116041552K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091748949150K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091177215850K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
573201611482014K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
573201437359262K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477092031753840K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477091584598161K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
573202023807060K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
573201196364771K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
3477091773021761K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
3477091068978934K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
573201858460119K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
573201536429839K885179INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELDDYB1989-08-09
573201715148902K883174MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLEDQY1988-10-14
573201113250618K873466EXCEL PULSED IRRIGATION/SUCTION SYSTEMFQH1987-11-06
3477091216484974K864330SHEAR FORCE GAUGEDXE1987-01-06
573201698557804K864330SHEAR FORCE GAUGEDXE1987-01-06
573201340817760K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSLXC1985-04-04
573201308823316K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
3477091904290553K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
573201057487737K823284STRYKER CONSTAVACGCY1983-01-14
3477091468888625K822723SWAN-GANZ BIPOLAR PACING CATHETERDYG1982-10-15
573201930792010K822723SWAN-GANZ BIPOLAR PACING CATHETERDYG1982-10-15
3477091509749320K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATHDYG1982-08-24
573201833494736K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATHDYG1982-08-24
573201994614558K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRS1982-07-02
3477091189017095K820222SWAN-GANZ VIP-CATHETERDYG1982-02-12
573201659232841K820222SWAN-GANZ VIP-CATHETERDYG1982-02-12
573201804163881K813521TRANSLUMINAL BIPOLAR PACING PROBELDF1982-03-15
3477091894594523K813521TRANSLUMINAL BIPOLAR PACING PROBELDF1982-03-15
573201053030216K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.DYG1981-09-25
3477091165348493K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.DYG1981-09-25
3477091361762553K811411SWAN-GANZ HEPARIN COATED, ETC. CATHETERKRB1981-06-12
573201450579396K811411SWAN-GANZ HEPARIN COATED, ETC. CATHETERKRB1981-06-12
573201167025030K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTIONDYG1981-03-27
3477091990791780K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTIONDYG1981-03-27
3477091130553587K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
573201926015187K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
573201547524568K810124SWAN-GANZ VIP THERMODILUTION CATHETERDYG1981-02-04
3477091735338808K810124SWAN-GANZ VIP THERMODILUTION CATHETERDYG1981-02-04
3477091414520258K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.LDF1981-01-16
573201461476754K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.LDF1981-01-16
3477091204896052K791183SWAN-GANZ FLOW-DIRECTED CATHETERLDF1979-07-12
573201934978439K791183SWAN-GANZ FLOW-DIRECTED CATHETERLDF1979-07-12
3477091480140132K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC2026-06-05
3477091262766667K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeJKA2026-04-10
3477091668444905K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS2025-03-21
3477091410580993K241330Fogarty Fortis Arterial Embolectomy CatheterDXE2024-07-02
3477091706424413K240078Fogarty Thru-Lumen Embolectomy CatheterDXE2024-08-28
3477091841495761K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)DYG2024-06-27
3477091568545864K233824Swan-Ganz catheterDYG2024-06-06
3477091770570868K233820Fogarty Arterial Embolectomy Catheter with Gate ValveDXE2024-05-22
3477091483808450K233819Fogarty Venous Thrombectomy CathetersDXE2024-05-22
3477091143591033K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE2024-05-20
3477091668237925K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformDYG2023-09-21
3477091799258073K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeGIM2023-11-27
3477091341439408K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference SensorDQK2023-06-09
3477091552156900K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsFMK2022-12-16
3477091020947707K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKA2023-03-10
3477091337307380K222117Swang-Ganz IQ pulmonary artery catheterDYG2022-12-09
3477091034676479K193466Swan-Ganz CathetersDYG2020-02-16
573201837403718K193466Swan-Ganz CathetersDYG2020-02-16
3477091079416708K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE2020-06-12
3477091199837785K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)DQE2018-02-20
3477091886550076K160645PreSep Oligon Oximetry CatheterDQE2016-06-16
573201988722880K160645PreSep Oligon Oximetry CatheterDQE2016-06-16
573201580725769K160084Swan Ganz CathetersDYG2016-05-03
3477091617448850K160084Swan Ganz CathetersDYG2016-05-03
573201024325559K152762Fogarty Occlusion CatheterMJN2015-11-23
3477091349384422K152762Fogarty Occlusion CatheterMJN2015-11-23
573201074327067K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeLDF2015-10-15
3477091662191292K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeLDF2015-10-15
573201173846042K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
3477091814657590K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
573201099988018K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKHQC2014-02-27
573201194039643K120509STRYKER ALL SUTURE ANCHORSMBI2012-07-26
573201348936197K113565MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARINFOZ2012-05-18
3477091608585947K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)DQE2011-02-18
573201961596683K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)DQE2011-02-18
573201634173206K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5KRB2010-12-07
3477091761273198K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5KRB2010-12-07
573201102320647K093911FOGARTY OCCLUSION CATHETERMJN2010-01-21
3477091904624959K093911FOGARTY OCCLUSION CATHETERMJN2010-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYG322024-06-27
DQE152018-02-20
DXE122024-08-28
LDF82015-10-15
FOZ62012-05-18
DYB62003-06-20
DQO62002-03-08
DXC52026-06-05
JKA52026-04-10
MJN42015-11-23
MBI42012-07-26
KRB42010-12-07
GEI42007-09-20
ERL42004-03-03
HIF32007-05-23
DQY32003-10-02
HQL32001-04-05
DRS22025-03-21
DXO22014-09-03
HRX22002-01-17
FQH21997-07-29
MCW21995-02-07
KRA21993-04-08
FGE21991-02-13
GIM12023-11-27
DQK12023-06-09
FMK12022-12-16
HQC12014-02-27
MSS12008-10-02
HWC12007-09-17
FMF12005-05-18
LJH12004-10-25
KNS12004-08-09
DZJ12004-04-01
HBE12004-01-16
GCJ12000-05-15
CAC11997-12-16
GCX11996-11-26
KCY11995-07-11
LXH11994-08-05