Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Edwards Lifeciences, LLC

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories3
Latest FDA decision2022-11-07
TypeNumberDevice NameCodeDateActions
510(k) K223127 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableDQK2022-11-07 View
510(k) K183646 Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureQAQ2019-05-21 View
510(k) K183413 TruWave Disposable Pressure TransducerDXO2019-05-01 View
↑