7 devices · 1 company · 2017 to 2025
Medtronic, Inc.: AI-enabled devices on FDA's list
7 devices from Medtronic, Inc., 2017 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Medtronic, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Aurora EV ICDP220012/S059 · PMA | Cardiovascular | LWS | database entry | |
| LINQ II Insertable Cardiac MonitorK233562 · 510(k) | Cardiovascular | MXD | database entry | |
| LINQ II Insertable Cardiac Monitor, CareLink SmaK230553 · 510(k) | Cardiovascular | MXD | database entry | |
| Reveal LINQ Insertable Cardiac Monitor, LINQ IIK223630 · 510(k) | Cardiovascular | MXD | database entry | |
| LINQ II Insertable Cardiac MonitorK221962 · 510(k) | Cardiovascular | MXD | database entry | |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECGK210484 · 510(k) | Cardiovascular | MXD | database entry | |
| Reveal LINQK162855 · 510(k) | Cardiovascular | MXD | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.