Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
Edwards Lifesciences, LLC has 129 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.
Latest FDA clearance: Feb 2026. Active since 1979.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Edwards Lifesciences, LLC
135 devices
Cleared
Feb 24, 2026
HemoSphere Nano Monitor (HSNANO1)
Cardiovascular
151d
Cleared
Sep 23, 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
Cardiovascular
88d
Cleared
Sep 17, 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
Cardiovascular
107d
Cleared
May 15, 2025
Hypertension Prediction Index (HePI) Algorithm
Cardiovascular
265d
Cleared
Mar 21, 2025
FloTrac sensors
Cardiovascular
178d
Cleared
Aug 28, 2024
Fogarty Thru-Lumen Embolectomy Catheter
Cardiovascular
230d
Cleared
Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
Cardiovascular
228d
Cleared
Jun 06, 2024
Swan-Ganz catheter
Cardiovascular
188d
Cleared
May 22, 2024
Fogarty Venous Thrombectomy Catheters
Cardiovascular
173d
Cleared
Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
Cardiovascular
256d
Cleared
Oct 31, 2023
HemoSphere Alta Advanced Monitoring Platform
Cardiovascular
91d
Cleared
Oct 24, 2023
Acumen IQ finger cuff
Cardiovascular
204d
Looking for a specific device from Edwards Lifesciences, LLC? Search by device name or K-number.
Search all Edwards Lifesciences, LLC devices