Edwards Lifesciences

FDA Filings

This page includes the latest FDA filings for Edwards Lifesciences. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Edwards Lifesciences LLC
Fem-flex Ii Femoral Arterial Cannula, Fem-flex Ii Femoral Venous Cannula, Femoral Venous Cannula, Femtrak Femoral Venous Cannula2020-03-13
Edwards Lifesciences
Edwards ESheath Introducer Set2020-03-09
Edwards Lifesciences, LLC
Swan-Ganz Catheters2020-02-16
Edwards Lifesciences, LLC
EV1000 Clinical Platform2019-12-17
Edwards Lifesciences LLC
Physio Flex Annuloplasty Ring2019-12-16
Edwards Lifesciences, LLC
EV1000 Clinical Platform NI, EV1000 Clinical Platform2019-08-30
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module2019-08-29
Edwards Lifesciences, LLC
The ClearSight Finger Cuffs2019-06-21
Edwards LifeSciences, LLC
Edwards Pressure Cable2019-06-13
Edwards Lifesciences, LLC
EV1000 Clinical Platform Non-Invasive (NI) With ClearSight Finger Cuffs Or ClearSight System2018-11-30
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere Pressure Cable2018-11-16
Edwards Lifesciences, LLC
VAMP Plus Venous/Arterial Blood Management Protection System2018-11-08
Edwards Lifesciences LLC
VAMP Optima Closed Blood Sampling System2018-10-24
Edwards Lifesciences, LLC
VAMP Venous/Arterial Blood Management Protection System2018-04-05
Edwards Lifesciences, LLC
Duravess Bovine Pericardial Vascular Patch2017-11-17
Edwards Lifesciences, LLC
TruWave Disposable Pressure Transducer2017-10-23
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable2017-04-14
Edwards Lifesciences LLC
IntraClude Intra-Aortic Occlusion Device2017-01-26
Edwards Lifesciences LLC
VAMP Venous/Arterial Blood Management Protection System2016-11-28
EDWARDS LIFESCIENCES, LLC
PreSep Oligon Oximetry Catheter2016-06-16
EDWARDS LIFESCIENCES, LLC
EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform2016-06-01
Edwards Lifesciences, LLC
Swan Ganz Catheters2016-05-03
Edwards Lifesciences, LLC
Flo Trac Sensor, Volume View Sensor2016-01-19
EDWARDS LIFESCIENCES
Edwards Balloon Catheter2016-01-07
EDWARDS LIFESCIENCES
Edwards ESheath Introducer Set2015-11-24
EDWARDS LIFESCIENCES, LLC.
Fogarty Occlusion Catheter2015-11-23
EDWARDS LIFESCIENCES, LLC
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe2015-10-15
EDWARDS LIFESCIENCES, LLC.
Edwards Suture Fastening System2015-06-16
EDWARDS LIFESCIENCES, LLC.
TruWave Disposable Pressure Transducer2015-01-18
EDWARDS LIFESCIENCES LLC.
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM2015-01-16

Latest Premarket Applications

PMAManufacturerDevice NameDate
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward2020-03-11
EDWARDS LIFESCIENCES, LLC.
EDWARDS INTUITY Elite Valve System2020-03-11
EDWARDS LIFESCIENCES, LLC.
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve2020-03-11
EDWARDS LIFESCIENCES, LLC.
EDWARDS INTUITY Elite Aortic Valve2020-03-05
EDWARDS LIFESCIENCES, LLC.
Edwards SAPIEN XT Transcatheter Heart Valve2020-03-05
EDWARDS LIFESCIENCES, LLC.
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve2020-03-05
EDWARDS LIFESCIENCES, LLC.
Sapien 3 Transcatheter Heart Valve and Accessories2020-03-05
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V2020-03-05
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE2020-03-05
EDWARDS LIFESCIENCES, LLC.
SAPIEN 3 Ultra Transcatheter Heart Valve System (THV)2020-01-16
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve2019-11-26
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Valves and Delivery Systems2019-11-26
EDWARDS LIFESCIENCES, LLC.
Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath2019-11-26
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral Bioprostheses2019-11-26
EDWARDS LIFESCIENCES, LLC.
Sapien XT Transcatheter Heart Valve2019-11-24
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial2019-11-24
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Valve System2019-11-24
EDWARDS LIFESCIENCES, LLC.
Sapien 3 Transcatheter Heart Valve and Ultra Transcatheter Heart Valve2019-11-24
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve2019-11-24
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Valve System2019-11-18
EDWARDS LIFESCIENCES, LLC.
Edwards Inspiris Resilia Aortic Valve2019-11-18
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial2019-11-18
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Delivery System2019-11-14
EDWARDS LIFESCIENCES, LLC.
Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Valve2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Sapien XT Transcatheter Heart Valve2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards eSheath Introducer Set2019-10-17
EDWARDS LIFESCIENCES, LLC.
Edwards Expandable Introducer Sheath Set2019-10-17

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Edwards Lifesciences LLC
Acumen Hypotension Prediction Index (HPI) Feature Software2018-03-16

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Edwards Lifesciences EZ Glide Aortic Cannula
Edwards Lifesciences LLC2020-03-19
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING WITH HOLDER
Edwards Lifesciences LLC2020-03-13
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING WITH HOLDER
Edwards Lifesciences LLC2020-03-12
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING WITH HOLDER
Edwards Lifesciences LLC2020-03-12
Edwards Lifesciences EZ Glide Aortic Cannula
Edwards Lifesciences LLC2020-03-11
ThinFlex Single Stage Venous Drainage Cannula
Edwards Lifesciences LLC2020-03-11
TRUWAVE
Edwards Lifesciences LLC2020-03-10
OptiSite Arterial Perfusion Cannula
Edwards Lifesciences LLC2020-03-09
EV1000
Edwards Lifesciences LLC2020-02-06
EV1000
Edwards Lifesciences LLC2020-02-06
EV1000
Edwards Lifesciences LLC2020-02-06
HemoSphere
Edwards Lifesciences LLC2020-02-06
HemoSphere
Edwards Lifesciences LLC2020-02-06
HemoSphere
Edwards Lifesciences LLC2020-02-06
NA
Edwards Lifesciences LLC2020-02-06
HemoSphere Tissue Oximetry Module
Edwards Lifesciences LLC2020-02-06
HEMOSPHERE
Edwards Lifesciences LLC2020-02-06
TRUWAVE
Edwards Lifesciences LLC2020-01-30
TRUWAVE
Edwards Lifesciences LLC2020-01-30
TRUWAVE
Edwards Lifesciences LLC2020-01-28
TRUWAVE
Edwards Lifesciences LLC2020-01-28
TRUWAVE
Edwards Lifesciences LLC2020-01-28
TRUWAVE
Edwards Lifesciences LLC2020-01-28
TRUWAVE
Edwards Lifesciences LLC2020-01-28
TRUWAVE
Edwards Lifesciences LLC2020-01-27
TRUWAVE
Edwards Lifesciences LLC2019-12-24
TRUWAVE
Edwards Lifesciences LLC2019-12-24
TRUWAVE
Edwards Lifesciences LLC2019-12-24
TRUWAVE
Edwards Lifesciences LLC2019-12-24
TRUWAVE
Edwards Lifesciences LLC2019-12-24
ClearSight
Edwards Lifesciences LLC2019-12-23
ClearSight
Edwards Lifesciences LLC2019-12-23
ClearSight
Edwards Lifesciences LLC2019-12-23
SWAN-GANZ CONTROLCATH TRUE SIZE
Edwards Lifesciences LLC2019-12-11
SWAN-GANZ VIP
Edwards Lifesciences LLC2019-12-11

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