Denny Kouri

FDA Filings

This page includes the latest FDA filings for Denny Kouri. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007063218
• FEI Number: 3007063218
• Name: Denny Kouri
• Owner & Operator: Edwards Lifesciences LLC
• Contact Address: One Edwards Way ; Irvine CA 92614 US
• Official Correspondent:
  • Denny Kouri
  • x-949-2502500-x
• US Agent:
  • Denny Kouri
  • EDWARDS LIFESCIENCES LLC
  • 949 2506827
  • Dennett_Kouri@edwards.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ONE EDWARDS WAY ; Irvine, CA 92614 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006379910
• FEI Number: 3006379910
• Name: Denny Kouri
• Owner & Operator: Edwards Lifesciences LLC
• Contact Address: One Edwards Way ; Irvine CA 92614 US
• Official Correspondent:
  • Denny Kouri
  • x-949-2502500-x
• US Agent:
  • Denny Kouri
  • Edwards Lifesciences, LLC
  • 949 2506827
  • Dennett_Kouri@edwards.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: One Edwards Way ; Irvine, CA 92614 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3015287573
• FEI Number: 3015287573
• Name: DENNY KOURI
• Owner & Operator: Edwards Lifesciences LLC
• Contact Address: One Edwards Way ; Irvine CA 92614 US
• Official Correspondent:
  • Denny Kouri
  • x-949-2502500-x
• US Agent:
  • DENNY KOURI
  • 949 2502500
  • Dennett_Kouri@edwards.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ONE EDWARDS WAY ; Irvine, CA 92614 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9615817
• FEI Number: 3003081151
• Name: Denny Kouri
• Owner & Operator: Edwards Lifesciences LLC
• Contact Address: One Edwards Way ; Irvine CA 92614 US
• Official Correspondent:
  • Denny Kouri
  • x-949-2502500-x
• US Agent:
  • Denny Kouri
  • EDWARDS LIFESCIENCES, LLC.
  • 949 2506827
  • Dennett_Kouri@edwards.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ONE EDWARDS WAY ; Irvine, CA 92614 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K190130 | DXN Denny Kouri [Edwards Lifesciences LLC]	ClearSight finger cuff	2019-07-10
PMN K190130 | DXN Denny Kouri [Edwards Lifesciences LLC]	Acumen IQ finger cuff	2019-07-10
PMN K183413 | DXO Denny Kouri [Edwards Lifesciences LLC]	TruWave Disposable Pressure Transducer	2019-05-07
PMN K161962 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP Venous/Arterial Blood Management Protection System	2019-03-08
PMN K181684 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP Plus Venous/Arterial Blood Management Protection System	2018-11-08
PMN K180275 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP Optima closed blood sampling system	2018-10-25
PMN K180275 | FPA Denny Kouri [Edwards Lifesciences LLC]	VAMP Optima closed blood sampling system	2018-10-25
PMN K180275 | FMG Denny Kouri [Edwards Lifesciences LLC]	VAMP Optima closed blood sampling system	2018-10-25
PMN K173586 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP Venous/Arterial Blood Management Protection System	2018-06-12
PMN K173586 | DXO Denny Kouri [Edwards Lifesciences LLC]	VAMP Venous/Arterial Blood Management Protection System	2018-06-12
PMN K171996 | DXO Denny Kouri [Edwards Lifesciences LLC]	TruWave	2017-11-03
PMN P150048 | LWR Denny Kouri [Edwards Lifesciences LLC]	INSPIRIS RESILIA Aortic Valve	2017-07-11
PMN P150048 | LWR Denny Kouri [Edwards Lifesciences LLC]	Edwards Pericardial Aortic Bioprosthesis	2017-07-11
FOX Denny Kouri [Edwards Lifesciences LLC]	TruClip	2016-12-14
PMN P150036 | LWR Denny Kouri [Edwards Lifesciences LLC]	EDWARDS INTUITY Elite Valve System	2016-08-17
PMN K160552 | DXN Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform	2016-06-21
PMN K160552 | DXN Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System	2016-06-21
PMN K160552 | DSB Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform	2016-06-21
PMN K160552 | DSB Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System	2016-06-21
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	VolumeView Sensor-VLV8R5	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	VolumeView Sensor-VLV6R5	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD8S102	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD8C503	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD8	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD85	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD6C502	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD6AZA	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD6AZ	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD6AZ5	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD6	2016-01-28
PMN K152980 | DRS Denny Kouri [Edwards Lifesciences LLC]	Flotrac Sensor-MHD65	2016-01-28
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	eSheath- 916ES	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	eSheath- 914ES	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 916ES	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 914ES	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Delivery System	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Crimper	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Commander Delivery System	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath Set	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Delivery System	2015-06-22
PMN P140031 | NPU Denny Kouri [Edwards Lifesciences LLC]	Edwards Axela Sheath	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	eSheath- 916ES	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	eSheath- 914ES	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 916ES	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 914ES	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Delivery System	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Crimper	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Commander Delivery System	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath Set	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Delivery System	2015-06-22
PMN P140031 | NPU DENNY KOURI [Edwards Lifesciences LLC]	Edwards Axela Sheath	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	eSheath- 916ES	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	eSheath- 914ES	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 916ES	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 914ES	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Delivery System	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Crimper	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Commander Delivery System	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath Set	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Certitude Delivery System	2015-06-22
PMN P140031 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Axela Sheath	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	eSheath- 916ES	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	eSheath- 914ES	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 916ES	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards eSheath Introducer Set- 914ES	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Ultra Delivery System	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards SAPIEN 3 Transcatheter Heart Valve	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Crimper	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Commander Delivery System	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Introducer Sheath Set	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Certitude Delivery System	2015-06-22
PMN P140031 | NPT DENNY KOURI [Edwards Lifesciences LLC]	Edwards Axela Sheath	2015-06-22
PMN K142749 | DXO Denny Kouri [Edwards Lifesciences LLC]	TruWave? Disposable Pressure Transducers	2015-01-20
PMN K142749 | DXO Denny Kouri [Edwards Lifesciences LLC]	Disposable Pressure Transducer	2015-01-20
PMN K141495 | DXO Denny Kouri [Edwards Lifesciences LLC]	TruWave Disposable Pressure Transducer	2014-09-11
PMN K141495 | DXO Denny Kouri [Edwards Lifesciences LLC]	Pressure Monitoring Kit with TruWave Disposable Pressure Transducers	2014-09-11
PMN K810162 | DXC Denny Kouri [Edwards Lifesciences LLC]	Fogarty Softjaw Spring Clip	2014-08-07
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Qualcrimp crimping accessory	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	NovaFlex+ System	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	NovaFlex + Delivery System	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN XT Transcatheter Heart Valve	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Edwards Expandable Introducer Sheath Set	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Edwards Dilator Kit	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Edwards Crimper	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Crimp Stopper	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Ascendra+ System	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Ascendra+ Delivery System	2014-06-18
PMN P130009 | NPV Denny Kouri [Edwards Lifesciences LLC]	Ascendra + Introducer Sheath Set	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Qualcrimp crimping accessory	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	NovaFlex+ System	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	NovaFlex + Delivery System	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards SAPIEN XT Transcatheter Heart Valve	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Expandable Introducer Sheath Set	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Dilator Kit	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Edwards Crimper	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Crimp Stopper	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Ascendra+ System	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Ascendra+ Delivery System	2014-06-18
PMN P130009 | NPT Denny Kouri [Edwards Lifesciences LLC]	Ascendra + Introducer Sheath Set	2014-06-18
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	EV1000NI	2014-06-16
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	EV1000 Non-Invasive	2014-06-16
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform NI	2014-06-16
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	Clearsight	2014-06-16
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	Clearsight system	2014-06-16
PMN K140312 | DXN Denny Kouri [Edwards Lifesciences LLC]	Clearsight finger cuff	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	EV1000NI	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	EV1000 Non-Invasive	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	EV1000 Clinical Platform NI	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	Clearsight	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	Clearsight system	2014-06-16
PMN K140312 | DSB Denny Kouri [Edwards Lifesciences LLC]	Clearsight finger cuff	2014-06-16
PMN K122381 | DXN Denny Kouri [Edwards Lifesciences LLC]	Nexfin Model 2	2014-02-14
PMN K122381 | DSB Denny Kouri [Edwards Lifesciences LLC]	Nexfin Model 2	2014-02-14
PMN K122381 | DQA Denny Kouri [Edwards Lifesciences LLC]	Nexfin Model 2	2014-02-14
PMN K101123 | DXN Denny Kouri [Edwards Lifesciences LLC]	ccNexfin	2013-01-02
PMN K101123 | DSB Denny Kouri [Edwards Lifesciences LLC]	ccNexfin	2013-01-02
PMN K101123 | DQA Denny Kouri [Edwards Lifesciences LLC]	ccNexfin	2013-01-02
PMN K072049 | DXN Denny Kouri [Edwards Lifesciences LLC]	Nexfin_HD	2013-01-02
PMN K072049 | DXN Denny Kouri [Edwards Lifesciences LLC]	Nexfin	2013-01-02
PMN K072049 | DSB Denny Kouri [Edwards Lifesciences LLC]	Nexfin_HD	2013-01-02
PMN K072049 | DSB Denny Kouri [Edwards Lifesciences LLC]	Nexfin	2013-01-02
PMN K896819 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP	2011-09-26
PMN K896819 | KRA Denny Kouri [Edwards Lifesciences LLC]	VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION	2011-09-26
DXC Denny Kouri [Edwards Lifesciences LLC]	Parallel Jaw Spring Clamp	2009-04-03
DXC Denny Kouri [Edwards Lifesciences LLC]	Handleless Clamp	2009-04-03
DXC Denny Kouri [Edwards Lifesciences LLC]	Fogarty	2009-04-03
DXC Denny Kouri [Edwards Lifesciences LLC]	Fogarty-Hydragrip Surg Clamp Insert	2009-04-03
DXC Denny Kouri [Edwards Lifesciences LLC]	EverGrip Insert	2009-04-03
PMN K833997 | DPW Denny Kouri [Edwards Lifesciences LLC]	CO-SET	2008-01-29
PMN K833997 | DPW Denny Kouri [Edwards Lifesciences LLC]	CO-SET+CLOSED INJECTATE SYSTEM	2008-01-29
PMN P860057 | DYE Denny Kouri [Edwards Lifesciences LLC]	Carpentier-Edwards Perimount Bioprosthesis	2008-01-17
PMN K925638 | DXO Denny Kouri [Edwards Lifesciences LLC]	TruWave Disposable Pressure Transducer	2007-12-17
PMN K925638 | DXO Denny Kouri [Edwards Lifesciences LLC]	TRUCLIP	2007-12-17
PMN K925638 | DXO Denny Kouri [Edwards Lifesciences LLC]	PX1800	2007-12-17
PMN K925638 | DXO Denny Kouri [Edwards Lifesciences LLC]	CATHETER TIP, PRESSURE TRANSDUCER	2007-12-17
PMN K821416 | DRS Denny Kouri [Edwards Lifesciences LLC]	Dome	2007-12-17
PMN K821416 | DRS Denny Kouri [Edwards Lifesciences LLC]	DISPOSABLE PRESSURE DOME	2007-12-17
PMN K832554 | DXC Denny Kouri [Edwards Lifesciences LLC]	VASCULAR CLAMP	2007-11-28
PMN K832554 | DXC Denny Kouri [Edwards Lifesciences LLC]	Fogarty	2007-11-28
PMN K832554 | DXC Denny Kouri [Edwards Lifesciences LLC]	Fogarty 6mm Spring Clip	2007-11-28
PMN K811399 | KRB Denny Kouri [Edwards Lifesciences LLC]	CO-SET	2007-11-28
GDJ Denny Kouri [Edwards Lifesciences LLC]	FOGARTY	1993-01-13

Similar & Related FDA Registered Companies

• Edwards Lifesciences, LLC