Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

135 results for "Edwards Lifesciences, LLC"
1–24 of 135
Cleared Feb 24, 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 151d
Cleared Sep 23, 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Sep 17, 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 107d
Cleared May 15, 2025
Hypertension Prediction Index (HePI) Algorithm
K242518 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared Mar 21, 2025
FloTrac sensors
K242909 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 178d
Cleared Aug 28, 2024
Fogarty Thru-Lumen Embolectomy Catheter
K240078 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 230d
Cleared Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
K233984 · QMS
Edwards Lifesciences, LLC
Cardiovascular · 228d
Cleared Jun 06, 2024
Swan-Ganz catheter
K233824 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · MUD
Edwards Lifesciences, LLC
Cardiovascular · 256d
Cleared Oct 31, 2023
HemoSphere Alta Advanced Monitoring Platform
K232294 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 91d
Cleared Oct 24, 2023
Acumen IQ finger cuff
K230919 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 204d
Cleared Aug 18, 2023
Smart Wedge algorithm
K230579 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 169d
Cleared Jul 26, 2023
Global Hypoperfusion Index (GHI) Algorithm
K231038 · QNL
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jul 12, 2023
FusedCO Algorithm
K231035 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 92d
Cleared Jun 09, 2023
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted...
K223865 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 168d
Cleared Jun 08, 2023
Acumen Hypotension Prediction Index (HPI) Algorithm
K230057 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared May 26, 2023
Cerebral Adaptive Index (CAI) Algorithm
K223651 · MUD
Edwards Lifesciences, LLC
Neurology · 171d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Nov 22, 2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global...
K221704 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 137d
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy...
K221528 · DXF
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K213682 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 212d
Cleared Feb 14, 2022
Fogarty Occlusion Catheter
K211610 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 265d