Manufacturer profileEdwards Lifesciences LLC
Manufacturer • United States of America242 devices on the TGA ARTG6 device classesNov 07, 2004 – Mar 21, 2025
VerifiedTGA · Australian Register of Therapeutic Goods
242
Total devices
6
Device classes
2004
Earliest registration
2025
Latest registration
Regulatory footprint
Search Edwards Lifesciences LLC across other regulatory registries
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South Korea
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EcuadorRecent device registrations
Latest 10 TGA ARTG device registrations
EVOQUE Tricuspid Valve Replacement System - Tricuspid transcatheter heart valve bioprosthesis
ARTG 483625Sponsor: Edwards Lifesciences Pty Ltd
Class III · Mar 21, 2025
Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 475371Sponsor: Edwards Lifesciences Pty Ltd
Class III · Jan 08, 2025
Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 475371Sponsor: Edwards Lifesciences Pty Ltd
Class III · Jan 08, 2025
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 471906Sponsor: Edwards Lifesciences Pty Ltd
Class III · Dec 05, 2024
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 471906Sponsor: Edwards Lifesciences Pty Ltd
Class III · Dec 05, 2024
Swan-Ganz IQ Pulmonary Arterial Catheter - Catheter, cardiac, balloon, thermal dilution
ARTG 468765Sponsor: Edwards Lifesciences Pty Ltd
Class III · Nov 14, 2024
Fogarty® Thru-Lumen Embolectomy Catheters - Embolectomy/thrombectomy balloon catheter
ARTG 461385Sponsor: Edwards Lifesciences Pty Ltd
Class IIa · Aug 29, 2024
Patient positioning sensor
ARTG 461367Sponsor: Edwards Lifesciences Pty Ltd
Class IIb · Aug 29, 2024
Tissue saturation oximeter
ARTG 461366Sponsor: Edwards Lifesciences Pty Ltd
Class IIb · Aug 29, 2024
Infusion controller, battery-powered
ARTG 459025Sponsor: Edwards Lifesciences Pty Ltd
Class IIa · Aug 09, 2024
Risk class distribution
Devices by risk class
Class I7129.3% of total
Class IIa3715.3% of total
Class IIb104.1% of total
Class III11447.1% of total
Class Is83.3% of total
Class Im20.8% of total
About this profile
Explore comprehensive manufacturer profile for Edwards Lifesciences LLC through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 242 medical devices registered with TGA ARTG across 6 device classes. This manufacturer is based in United States of America. Their registration history spans from Nov 07, 2004 to Mar 21, 2025.
This page provides detailed insights including recent device registrations, risk class distribution (Class I: 71, Class III: 114, Class Is: 8, Class IIa: 37, Class IIb: 10, Class Im: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's medical device registry with 62k records.