3 devices · 2 companies · 2018 to 2024
Edwards Lifesciences, LLC: AI-enabled devices on FDA's list
3 devices from Edwards Lifesciences, LLC, 2018 to 2024, from 2 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Edwards Lifesciences, LLC
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Acumen Assisted Fluid ManagementK233984 · 510(k) | Cardiovascular | QMS | database entry | |
| Global Hypoperfusion IndexK231038 · 510(k) | Cardiovascular | QNL | database entry | |
| Acumen Hypotension Prediction IndexDEN160044 · De Novo | Cardiovascular | QAQ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.