DeviceClearance

Product code MXD— Cardiovascular

Reveal LINQ

Classification name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Total cleared
34
First cleared
Most recent

Market context for product code MXD

FDA has cleared 34 devices under product code MXD between 2014 and 2026, filed by 6 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.

Clearances per year

Top applicants under product code MXD

Adverse events under product code MXD

product code MXD
Injury
1,880
Malfunction
9,487
Total
11,367

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

Recent clearances under product code MXD

Data sourced from openFDA. This site is unofficial and independent of the FDA.