8 devices · 3 companies · 2017 to 2025
Product code MXD: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
8 devices under product code MXD, 2017 to 2025, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection). 21 CFR 870.1025, Class II. MAUDE held 13,169 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Assert-IQK253516 · 510(k) | Abbott Medical | Cardiovascular | database entry | |
| Assert-IQK251221 · 510(k) | Abbott | Cardiovascular | database entry | |
| LINQ II Insertable Cardiac MonitorK233562 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry | |
| LINQ II Insertable Cardiac Monitor, CareLink SmaK230553 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry | |
| Reveal LINQ Insertable Cardiac Monitor, LINQ IIK223630 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry | |
| LINQ II Insertable Cardiac MonitorK221962 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry | |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECGK210484 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry | |
| Reveal LINQK162855 · 510(k) | Medtronic, Inc. | Cardiovascular | database entry |
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