Insertable cardiac monitors
FDA decisions under product codes MXD, MXC, as the FDA record prints them, with the owning organisation and the Health Canada licence the registry pairs to the decision. 2 decisions.
| Device (FDA record) | Owner | FDA decision | Health Canada licence |
|---|---|---|---|
| BIOMONITOR IV (471155)Biotronik, Inc. | Biotronik | 510(k) 2026-05-01K261074 · JSON · ArrHub record | No licence as at 14 October 2026 |
| LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc. | Medtronic | 510(k) 2026-08-28K262735 · JSON · ArrHub record | No licence as at 14 October 2026 |
The registry and this page start at 1 January 2019.
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