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Edwards Lifesciences, LLC FDA Approvals
0 new drug approvals and 29 device clearances on file. Matched by name to EW.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Respiration Rate algorithm510(k)Jun 11, 2026Anesthesiology |
| HemoSphere Nano Monitor (HSNANO1)510(k)Feb 24, 2026Cardiovascular |
| Edwards MC3 Tricuspid annuloplasty ring (4900)510(k)Sep 23, 2025Cardiovascular |
| Carpentier-Edwards Physio Annuloplasty Ring (4450)510(k)Sep 17, 2025Cardiovascular |
| Hypertension Prediction Index (HePI) Algorithm510(k)May 15, 2025Cardiovascular |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors510(k)Mar 21, 2025Cardiovascular |
| Fogarty Thru-Lumen Embolectomy Catheter510(k)Aug 28, 2024Cardiovascular |
| Acumen Assisted Fluid Management (AFM) Software Feature510(k)Aug 2, 2024Cardiovascular |
| Swan-Ganz catheter510(k)Jun 6, 2024Cardiovascular |
| Fogarty Venous Thrombectomy Catheters510(k)May 22, 2024Cardiovascular |
| Edwards Algorithm for Measurement of Blood Hemoglobin510(k)Nov 17, 2023Cardiovascular |
| HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)510(k)Oct 31, 2023Cardiovascular |
| Acumen IQ finger cuff510(k)Oct 24, 2023Cardiovascular |
| Smart Wedge algorithm510(k)Aug 18, 2023Cardiovascular |
| Global Hypoperfusion Index (GHI) Algorithm510(k)Jul 26, 2023Cardiovascular |
| FusedCO Algorithm510(k)Jul 12, 2023Cardiovascular |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor510(k)Jun 9, 2023Cardiovascular |
| Acumen Hypotension Prediction Index (HPI) Algorithm510(k)Jun 8, 2023Cardiovascular |
| Cerebral Adaptive Index (CAI) Algorithm510(k)May 26, 2023Cardiovascular |
| TruWave Disposable Pressure Transducer510(k)Dec 22, 2022Cardiovascular |
| HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)510(k)Nov 22, 2022Cardiovascular |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module510(k)Nov 7, 2022Cardiovascular |
| Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter510(k)Aug 22, 2022Cardiovascular |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote510(k)Jun 22, 2022Cardiovascular |
| Fogarty Occlusion Catheter510(k)Feb 14, 2022Cardiovascular |
| Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform510(k)Jul 30, 2021Cardiovascular |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index510(k)May 28, 2021Cardiovascular |
| FORE-SIGHT ELITE Absolute Tissue Oximeter510(k)Feb 10, 2021Cardiovascular |
| EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform510(k)Jan 22, 2021Cardiovascular |