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)
Top companies in MXC
| Company | 510(k)s | Recalls |
|---|---|---|
| St Jude Medical | 6 | 2 |
| Abbott (St. Jude Medical) | 5 | 0 |
| Medtronic Vascular | 4 | 0 |
| Abbott | 2 | 1 |
| Transoma Medical | 2 | 0 |
| ABBOTT MEDICAL | 1 | 0 |
| St. Jude Medical, Cardiac Rhythm Management Divisi | 1 | 0 |
| St Jude Medical, Cardiac Rhythm Management Division | 0 | 1 |
| St Jude Medical CRMD | 0 | 1 |
| Transnoma Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2023 | K230286 | Assert-IQ Insertable Cardiac Monitor ABBOTT MEDICAL | MXC |
| Aug 13, 2021 | K212206 | Jot Dx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Dec 1, 2020 | K202876 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Nov 23, 2020 | K202888 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Mar 17, 2020 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) | MXC |
| Oct 18, 2019 | K192593 | Confirm Rx Insertable Cardiac Monitor Abbott | MXC |
| Apr 10, 2019 | K190295 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Mar 29, 2019 | K182981 | Confirm Rx Insertable Cardiac Monitor Abbott | MXC |
| Nov 2, 2017 | K173232 | myMerlin(TM) Mobile Application Model APP1001 St Jude Medical | MXC |
| Sep 29, 2017 | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. | MXC |
| May 28, 2014 | K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) St. Jude Medical, Inc. | MXC |
| Nov 28, 2012 | K122161 | SJM CONFIRM St Jude Medical | MXC |
| Nov 15, 2012 | K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR St. Jude Medical, Cardiac Rhythm Management Divisi | MXC |
| Sep 15, 2010 | K101968 | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A St Jude Medical | MXC |
| May 18, 2009 | K091206 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL Transoma Medical | MXC |
| Feb 11, 2009 | K083828 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT Transoma | MXC |
| Aug 15, 2008 | K081365 | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR St Jude Medical | MXC |
| Dec 3, 2007 | K073147 | SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 Transoma Medical | MXC |
| Oct 1, 2007 | K063035 | SLEUTH IMPLANTABLE ECG MONITORING SYSTEM Transnoma Medical, Inc. | MXC |
| May 4, 2001 | K011098 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular | MXC |
| Feb 14, 2001 | K003667 | REVEAL PLUS INSERTABLE LOOP RECORDER Medtronic Vascular | MXC |
| Jan 21, 2000 | K994331 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular | MXC |
| Jan 16, 1998 | K972242 | REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM Medtronic Vascular | MXC |
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