Product code

AI devices with FDA product code MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Product code MXD (“Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)” in openFDA) covers 8 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Cardiovascular panel (8). The most recent decision was Assert-IQ (DM5100) on December 18, 2025.

8AI devices
3Companies
2017First decision
2025-12-18Latest decision

Trend: devices per year

2017: 12021: 12022: 12023: 32025: 2
20172021202220232025
AI devices with FDA product code MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) per year: 2017 1, 2021 1, 2022 1, 2023 3, 2025 2

All 8 devices, newest first