Device type
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Product code MXD · Class II · 21 CFR 870.1025 · Cardiovascular
Recent 510(k)s
Aug 28, 2026
K262735
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
Medtronic, Inc.
- MXD
- Class II
Recent recalls
Sep 9, 2026
Z-3081-2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing
Sep 9, 2026
Z-3083-2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing
Sep 9, 2026
Z-3082-2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing