DeviceClearance

Product code DXJ— Cardiovascular

Philips IntelliVue GuardianSoftware

Classification name
Display, Cathode-Ray Tube, Medical
Device class
Class 2
Regulation
21 CFR 870.2450
Advisory panel
Cardiovascular
Total cleared
78
First cleared
Most recent

Market context for product code DXJ

FDA has cleared 78 devices under product code DXJ between 1976 and 2021, filed by 42 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 DXJ

Adverse events under product code DXJ

product code DXJ
Death
2
Total
2

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 DXJ

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