DeviceClearance

Product code MHX— Cardiovascular

PATIENT MONITOR

Classification name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Total cleared
429
First cleared
Most recent

Market context for product code MHX

FDA has cleared 429 devices under product code MHX between 1987 and 2026, filed by 114 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

last 15 years

Top applicants under product code MHX

Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

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 MHX

1–100 of 429

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