Panels › Cardiovascular › Product code MXD · Class 2
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation 870.1025
3510(k)s in 12 months (34 all time)
5recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in MXD
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic, Inc. | 17 | 1 |
| Biotronik, Inc. | 11 | 0 |
| Boston Scientific Corp | 4 | 6 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 0 | 3 |
| Abbott | 1 | 0 |
| ABBOTT MEDICAL | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) Medtronic, Inc. | MXD |
| May 1, 2026 | K261074 | BIOMONITOR IV (471155) Biotronik, Inc. | MXD |
| Dec 18, 2025 | K253516 | Assert-IQ (DM5100) ABBOTT MEDICAL | MXD |
| Sep 17, 2025 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) Abbott | MXD |
| Sep 12, 2025 | K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) Boston Scientific Corporation | MXD |
| Mar 28, 2024 | K240693 | LINQ II Insertable Cardiac Monitor (ICM) Medtronic, Inc. | MXD |
| Dec 6, 2023 | K233562 | LINQ II Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| Oct 31, 2023 | K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) Medtronic, Inc. | MXD |
| Aug 19, 2023 | K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp | MXD |
| May 19, 2023 | K230375 | BIOMONITOR IV Biotronik, Inc. | MXD |
| Apr 26, 2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application Medtronic, Inc. | MXD |
| Apr 5, 2023 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System Medtronic, Inc. | MXD |
| Aug 25, 2022 | K221962 | LINQ II Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| Jul 27, 2022 | K221856 | BIOMONITOR IIIm, BIOMONITOR III Biotronik, Inc. | MXD |
| Jul 22, 2021 | K212008 | Reveal LINQ Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| Jun 11, 2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System Medtronic, Inc. | MXD |
| May 28, 2021 | K211304 | LINQ II Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| May 25, 2021 | K210608 | LUX-Dx Insertable Cardiac Monitor Boston Scientific Corporation | MXD |
| Dec 8, 2020 | K201865 | Biomonitor III, Biomonitor IIIm Biotronik, Inc. | MXD |
| Jul 3, 2020 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool K Medtronic, Inc. | MXD |
| Jun 26, 2020 | K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Serv Boston Scientific Corporation | MXD |
| Apr 23, 2020 | K200444 | Biomonitor III, Biomonitor IIIm Biotronik, Inc. | MXD |
| Jul 5, 2019 | K190548 | BIOMONITOR III, Remote Assistant III Biotronik, Inc. | MXD |
| Jun 29, 2017 | K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set Biotronik, Inc. | MXD |
| Mar 31, 2017 | K170628 | BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. | MXD |
| Feb 23, 2017 | K162855 | Reveal LINQ Medtronic, Inc. | MXD |
| Feb 14, 2017 | K163460 | Reveal LINQ Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| May 26, 2016 | K160809 | Reveal LINQ Medtronic, Inc. | MXD |
| Apr 22, 2016 | K160689 | Reveal LINQ Medtronic, Inc. | MXD |
| Apr 11, 2016 | K152995 | BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. | MXD |
| Aug 6, 2015 | K150614 | Reveal LINQ Medtronic, Inc. | MXD |
| Mar 19, 2015 | K143503 | BioMonitor Biotronik, Inc. | MXD |
| Jun 6, 2014 | K132960 | BIOMONITOR Biotronik, Inc. | MXD |
| Feb 14, 2014 | K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR Medtronic, Inc. | MXD |
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