ClearanceBrief
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)
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Top companies in MXD

Company510(k)sRecalls
Medtronic, Inc.171
Biotronik, Inc.110
Boston Scientific Corp46
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)03
Abbott10
ABBOTT MEDICAL10
DateFirm and productCodeLinked 510(k)
Sep 2, 2026Boston Scientific Corporation
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)
Open, Classified		 MXDK231328
Sep 2, 2026Boston Scientific Corporation
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)
Open, Classified		 MXDK231328
Sep 2, 2026Boston Scientific Corporation
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)
Open, Classified		 MXDK231328
May 1, 2026Boston Scientific Corporation
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Vers
Open, Classified		 MXDK231328
May 1, 2026Boston Scientific Corporation
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Open, Classified		 MXDK231328
Oct 25, 2024Boston Scientific Corporation
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Open, Classified		 MXDK231328
Dec 1, 2023Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Open, Classified		 MXDK200795
K211304 +4
Jan 18, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
LINQ II Insertable Cardiac Monitor
Terminated		 MXDK200795
Jul 14, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Open, Classified		 MXDK200795
Jun 1, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Reveal LINQ LNQ11 / PA96000
Open, Classified		 MXDK162855

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