ClearanceBrief
Panels › Cardiovascular › Product code MXC · Class 2

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Regulation 870.2800

0510(k)s in 12 months (23 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in MXC

Company510(k)sRecalls
St Jude Medical62
Abbott (St. Jude Medical)50
Medtronic Vascular40
Abbott21
Transoma Medical20
ABBOTT MEDICAL10
St. Jude Medical, Cardiac Rhythm Management Divisi10
St Jude Medical, Cardiac Rhythm Management Division01
St Jude Medical CRMD01
Transnoma Medical, Inc.10
DateFirm and productCodeLinked 510(k)
Apr 25, 2019Abbott
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wire
Terminated		 MXCK163407
Apr 16, 2018St Jude Medical Inc.
Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the p
Terminated		 MXCK163407
Apr 16, 2018St Jude Medical Inc.
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained
Terminated		 MXCK163407
Apr 13, 2018St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Manag
Terminated		 MXCK163407
Jul 5, 2011St Jude Medical CRMD
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing i
Terminated		 MXCK081365

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