Product code MXC— Cardiovascular

FDA has cleared 23 devices under product code MXC between 1998 and 2023, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20211 clearance
• 20203 clearances
• 20193 clearances
• 20172 clearances
• 20141 clearance
• 20122 clearances
• 20101 clearance
• 20092 clearances
• 20081 clearance
• 20072 clearances
• 20012 clearances
• 20001 clearance
• 19981 clearance

• Abbott (St. Jude Medical)5 clearances
• St Jude Medical4 clearances
• Medtronic Vascular4 clearances
• Transoma Medical2 clearances
• St. Jude Medical, Inc.2 clearances
• Abbott2 clearances
• Transoma1 clearance
• Transnoma Medical, Inc.1 clearance
• St. Jude Medical, Cardiac Rhythm Management Divisi1 clearance
• ABBOTT MEDICAL1 clearance

Death

4

Injury

758

Malfunction

5,066

Total

5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K230286 — Assert-IQ Insertable Cardiac MonitorABBOTT MEDICAL·2023-05-17
• K212206 — Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)·2021-08-13
• K202876 — Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)·2020-12-01
• K202888 — Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)·2020-11-23
• K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical)·2020-03-17
• K192593 — Confirm Rx Insertable Cardiac MonitorAbbott·2019-10-18
• K190295 — Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)·2019-04-10
• K182981 — Confirm Rx Insertable Cardiac MonitorAbbott·2019-03-29
• K173232 — myMerlin(TM) Mobile Application Model APP1001St Jude Medical·2017-11-02
• K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.·2017-09-29
• K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)St. Jude Medical, Inc.·2014-05-28
• K122161 — SJM CONFIRMSt Jude Medical·2012-11-28
• K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITORSt. Jude Medical, Cardiac Rhythm Management Divisi·2012-11-15
• K101968 — SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100ASt Jude Medical·2010-09-15
• K091206 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODELTransoma Medical·2009-05-18
• K083828 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KITTransoma·2009-02-11
• K081365 — SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATORSt Jude Medical·2008-08-15
• K073147 — SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08Transoma Medical·2007-12-03
• K063035 — SLEUTH IMPLANTABLE ECG MONITORING SYSTEMTransnoma Medical, Inc.·2007-10-01
• K011098 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATORMedtronic Vascular·2001-05-04
• K003667 — REVEAL PLUS INSERTABLE LOOP RECORDERMedtronic Vascular·2001-02-14
• K994331 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATORMedtronic Vascular·2000-01-21
• K972242 — REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEMMedtronic Vascular·1998-01-16