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Edwards Lifesciences LLC

Manufacturer • United States of America · 242 devices on the TGA ARTG · 6 device classes · Nov 07, 2004 – Mar 21, 2025

242
Total Devices
6
Device Classes
2004
Earliest
2025
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
EVOQUE Tricuspid Valve Replacement System - Tricuspid transcatheter heart valve bioprosthesis
ARTG 483625
Class IIIMar 21, 2025
Sponsor: Edwards Lifesciences Pty Ltd
Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 475371
Class IIIJan 08, 2025
Sponsor: Edwards Lifesciences Pty Ltd
Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 475371
Class IIIJan 08, 2025
Sponsor: Edwards Lifesciences Pty Ltd
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 471906
Class IIIDec 05, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
ARTG 471906
Class IIIDec 05, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Swan-Ganz IQ Pulmonary Arterial Catheter - Catheter, cardiac, balloon, thermal dilution
ARTG 468765
Class IIINov 14, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Fogarty® Thru-Lumen Embolectomy Catheters - Embolectomy/thrombectomy balloon catheter
ARTG 461385
Class IIaAug 29, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Patient positioning sensor
ARTG 461367
Class IIbAug 29, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Tissue saturation oximeter
ARTG 461366
Class IIbAug 29, 2024
Sponsor: Edwards Lifesciences Pty Ltd
Infusion controller, battery-powered
ARTG 459025
Class IIaAug 09, 2024
Sponsor: Edwards Lifesciences Pty Ltd
View All 242 Devices →
Risk class distribution
Devices by risk class
Class I
71
29.3% of total
Class IIa
37
15.3% of total
Class IIb
10
4.1% of total
Class III
114
47.1% of total
Class Is
8
3.3% of total
Class Im
2
0.8% 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 complete medical device registry with 131,000+ devices.

Free Manufacturer ProfilePowered by Pure Global AI242 Devices6 Device Classes