EDWARDS LIFESCIENCES, LLC

FDA Filings

This page includes the latest FDA filings for EDWARDS LIFESCIENCES, LLC. 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
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
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable2017-04-14
Edwards Lifesciences LLC
VAMP Venous/Arterial Blood Management Protection System2016-11-28
EDWARDS LIFESCIENCES, LLC
PreSep Oligon Oximetry Catheter2016-06-16
Edwards Lifesciences, LLC
Swan Ganz Catheters2016-05-03
Edwards Lifesciences, LLC
Flo Trac Sensor, Volume View Sensor2016-01-19
EDWARDS LIFESCIENCES
Edwards ESheath Introducer Set2015-11-24
EDWARDS LIFESCIENCES, LLC.
TruWave Disposable Pressure Transducer2015-01-18
EDWARDS LIFESCIENCES
Ascendra Balloon Aortic Valvaloplasty Catheter2014-10-29
EDWARDS LIFESCIENCES, LLC.
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER2014-09-03
EDWARDS LIFESCIENCES, LLC.
EDWARDS TRANSFEMORAL BALLOON CATHETER2014-07-03
EDWARDS LIFESCIENCES, LLC.
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM2014-06-13
EDWARDS LIFESCIENCES, LLC.
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR2014-05-22
EDWARDS LIFESCIENCES, LLC.
EV1000 CLINICAL PLATFORM2014-05-22
EDWARDS LIFESCIENCES, LLC.
EDWARDS EMBOL-X INTRODUCER SHEATH2013-07-24
EDWARDS LIFESCIENCES, LLC.
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA2013-03-13
EDWARDS LIFESCIENCES, LLC.
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING2012-05-08
EDWARDS LIFESCIENCES, LLC.
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R52010-12-07
EDWARDS LIFESCIENCES, LLC.
RETROFLEX DILATOR KIT2010-04-13
EDWARDS LIFESCIENCES, LLC.
FOGARTY OCCLUSION CATHETER2010-01-21
EDWARDS LIFESCIENCES, LLC.
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 52002009-01-23

Latest Premarket Applications

PMAManufacturerDevice NameDate
EDWARDS LIFESCIENCES, LLC.
Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath2019-11-26
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve2019-11-26
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral Bioprostheses2019-11-26
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Valves and Delivery Systems2019-11-26
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.
Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial2019-11-24
EDWARDS LIFESCIENCES, LLC.
Sapien XT 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 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 Valve System2019-11-18
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Delivery System2019-11-14
EDWARDS LIFESCIENCES, LLC.
Edwards Sapien XT Transcatheter Heart 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.
Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Valve2019-10-28
EDWARDS LIFESCIENCES, LLC.
Edwards Expandable Introducer Sheath Set2019-10-17
EDWARDS LIFESCIENCES, LLC.
Edwards eSheath Introducer Set2019-10-17
EDWARDS LIFESCIENCES, LLC.
Edwards INSPIRIS RESILIA Aortic Valve2019-10-10
EDWARDS LIFESCIENCES, LLC.
Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves2019-10-03
EDWARDS LIFESCIENCES, LLC.
Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System2019-09-30
EDWARDS LIFESCIENCES, LLC.
Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER2019-09-24
EDWARDS LIFESCIENCES, LLC.
Edwards Intuity Elite Valve System2019-09-24
EDWARDS LIFESCIENCES, LLC.
Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve2019-09-24
EDWARDS LIFESCIENCES, LLC.
Sapien 3 Transcatheter Heart Valve and Accessories2019-09-17
EDWARDS LIFESCIENCES, LLC.
Sapien XT Transcatheter Heart Valve and Accessories2019-09-17
EDWARDS LIFESCIENCES, LLC.
SAPIEN 3 Transcatheter Heart Valve and Accessories2019-08-21
EDWARDS LIFESCIENCES, LLC.
SAPIEN 3 Ultra transcatheter heart valve2019-08-16

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
CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
Edwards Lifesciences LLC2019-11-26
HemoSphere Tissue Oximetry Module
Edwards Lifesciences LLC2019-11-26
HemoSphere
Edwards Lifesciences LLC2019-10-23
TRUWAVE
Edwards Lifesciences LLC2019-10-23
TRUWAVE
Edwards Lifesciences LLC2019-10-23
TRUWAVE
Edwards Lifesciences LLC2019-10-23
Edwards Lifesciences EZ Glide Aortic Cannula
Edwards Lifesciences LLC2019-10-22
TRUWAVE
Edwards Lifesciences LLC2019-10-21
TRUWAVE
Edwards Lifesciences LLC2019-10-21
VAMP
Edwards Lifesciences LLC2019-10-02
TruWave, VAMP Plus
Edwards Lifesciences LLC2019-10-02
VAMP
Edwards Lifesciences LLC2019-10-01
TRUWAVE, VAMP
Edwards Lifesciences LLC2019-09-23
Thin-Flex Dual Stage Venous Drainage Cannula
Edwards Lifesciences LLC2019-09-16
TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM)
Edwards Lifesciences LLC2019-07-24
TRUWAVE
Edwards Lifesciences LLC2019-07-17
ACUMEN IQ SENSOR
Edwards Lifesciences LLC2019-07-17
ACUMEN IQ SENSOR FOR AFM
Edwards Lifesciences LLC2019-07-17
TruWave, VAMP Plus
Edwards Lifesciences LLC2019-07-17
TruWave, VAMP Plus
Edwards Lifesciences LLC2019-07-17
TRUWAVE/ VAMP PLUS
Edwards Lifesciences LLC2019-07-11
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)
Edwards Lifesciences LLC2019-06-19
EDWARDS ESHEATH INTRODUCER SET
Edwards Lifesciences LLC2019-06-19
EDWARDS ESHEATH INTRODUCER SET
Edwards Lifesciences LLC2019-06-19
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC2019-06-19
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC2019-06-19
SAPIEN 3 Ultra delivery system
Edwards Lifesciences LLC2019-06-19
SAPIEN 3 Ultra Delivery System
Edwards Lifesciences LLC2019-06-19
SAPIEN 3 Ultra Delivery System
Edwards Lifesciences LLC2019-06-19
SAPIEN 3 Ultra delivery system
Edwards Lifesciences LLC2019-06-19
EDWARDS CRIMPER
Edwards Lifesciences LLC2019-06-19
AViD Dual Stage Venous Drainage Cannula
Edwards Lifesciences LLC2019-06-12
Thin-Flex Single Stage Venous Drainage Cannula
Edwards Lifesciences LLC2019-06-12
Thin-Flex Single Stage Venous Drainage Cannula
Edwards Lifesciences LLC2019-06-12
ThinFlex Single Stage Venous Drainage Cannula
Edwards Lifesciences LLC2019-06-12

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