Transparency Registry · applicant
Edwards Lifesciences, LLC: 1 FDA AI clearance
Every 510(k) clearance held by Edwards Lifesciences, LLC under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| Acumen Assisted Fluid Management (AFM) Software Feature | 2024-08-02 | QMS |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Edwards Lifesciences, LLC? The disclosure rows on your entries update free on submission of public links — start here.
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