Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
FDA product code MXD · 30 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1025
- Review panel
- CV
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2016-04-11 – 2026-08-28
MXD
2026-08-28
MXD
2026-05-01
BIOMONITOR IV (471155)
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MXD
2025-12-18
Assert-IQ (DM5100)
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MXD
2025-09-17
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
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MXD
2025-09-12
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
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MXD
2024-03-28
LINQ II™ Insertable Cardiac Monitor (ICM)
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MXD
2023-12-06
LINQ II Insertable Cardiac Monitor
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MXD
2023-10-31
LINQ II™ Insertable Cardiac Monitor (LNQ22)
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MXD
2023-08-19
LUX-Dx II (M302); LUX-Dx II+ (M312)
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MXD
2023-05-19
BIOMONITOR IV
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MXD
2023-04-26
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
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MXD
2023-04-05
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
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MXD
2022-08-25
LINQ II Insertable Cardiac Monitor
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MXD
2022-07-27
BIOMONITOR IIIm, BIOMONITOR III
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MXD
2021-07-22
Reveal LINQ Insertable Cardiac Monitor
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MXD
2021-06-11
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
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MXD
2021-05-28
LINQ II Insertable Cardiac Monitor
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MXD
2021-05-25
LUX-Dx Insertable Cardiac Monitor
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MXD
2020-12-08
Biomonitor III, Biomonitor IIIm
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MXD
2020-07-03
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
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MXD
2020-06-26
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
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MXD
2020-04-23
Biomonitor III, Biomonitor IIIm
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MXD
2019-07-05
BIOMONITOR III, Remote Assistant III
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MXD
2017-06-29
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
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MXD
2017-03-31
BioMonitor 2-AF, BioMonitor 2-S
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MXD
2017-02-23
Reveal LINQ
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MXD
2017-02-14
Reveal LINQ Insertable Cardiac Monitor
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MXD
2016-05-26
Reveal LINQ
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MXD
2016-04-22
Reveal LINQ
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MXD
2016-04-11
BioMonitor 2-AF, BioMonitor 2-S
View details →No matching devices.
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