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Informational only. Not affiliated with any government agency. Verify details at the official source.

Devices

Edwards Lifeciences, LLC

1 AI-enabled device listing under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
May 21, 2019K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureCardiovascularQAQ