FDA.reportPublic FDA data

Denny Kouri Kouri

Matched from indexed company URL: Denny Kouri

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063799103006379910Denny Kouri Kouri1N2026-01-01One Edwards Way Irvine CA US 92614
30152875733015287573DENNY KOURI1N2026-01-01ONE EDWARDS WAY Irvine CA US 92614
30172985883017298588Denny Kouri1N2026-01-01One Edwards Way Irvine CA US 92614
96158173003081151Denny Kouri1N2020-04-25ONE EDWARDS WAY Irvine CA US 92614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2281261251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
3063451875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
3063451675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
2281261356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
3063451156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
2281261156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
2281261268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
573241749391495K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
2281261565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
573241200607658K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
573241349899943K833997CO-SET1984-04-17
573241308823316K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
573241994614558K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRS1982-07-02
573241959202300K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEMKRB1981-06-09
573241926015187K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
2281261794933339K251982Edwards MC3 Tricuspid annuloplasty ring (4900)KRH2025-09-23
2281261623759230K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH2025-09-17
3063451643867828K200258Edwards eSheath Introducer SetDYB2020-03-09
2281261301009376K192762Physio Flex Annuloplasty RingKRH2019-12-16
573241670155142K190130The ClearSight finger cuffsDXN2019-06-21
573241728602474K183413TruWave Disposable Pressure TransducerDXO2019-05-01
573241165928081K181684VAMP Plus Venous/Arterial Blood Management Protection SystemKRA2018-11-08
573242003304713K180275VAMP Optima closed blood sampling systemKRA2018-10-24
573241479686108K173586VAMP Venous/Arterial Blood Management Protection SystemKRA2018-04-05
573241329601746K171996TruWave Disposable Pressure TransducerDXO2017-10-23
573241539963573K161962VAMP Venous/Arterial Blood Management Protection SystemKRA2016-11-28
573241085157824K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformDXN2016-06-01
573241453790904K152980Flo Trac sensor, Volume View sensorDRS2016-01-19
573241251101753K142749TruWave Disposable Pressure TransducerDXO2015-01-18
573241173846042K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
1511011832023475K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEMDXN2014-06-13
1511011614207012K122381NEXFIN MODEL 2DXN2013-04-22
2281261294418618K103520CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RINGKRH2011-06-24
1511011674528698K101123NEXFIN MODEL 2DXN2010-10-28
2281261207544903K083623CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100KRH2009-04-15
2281261212390437K083470CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200KRH2009-01-23
1511011035581695K072049CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICSDXN2007-11-29
2281261240403258K020864EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900KRH2002-04-17
573241214141132
573241773855827
573242029800478
3063451591930772

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRH92025-09-23
DXN62019-06-21
DXO52019-05-01
KRA52018-11-08
DRS22016-01-19
NPT22015-06-17
DXC21983-09-29
NKM 12022-09-14
NPV 12020-08-31
DYB12020-03-09
LWR12017-06-29
DYE11991-09-26
KRB11981-06-09