DeviceClearance

Product code IZQ— Cardiovascular

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Classification name
Injector, Contrast Medium, Automatic
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Total cleared
23
First cleared
Most recent

Market context for product code IZQ

FDA has cleared 23 devices under product code IZQ between 1976 and 2026, filed by 14 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 IZQ

Adverse events under product code IZQ

product code IZQ
Death
7
Total
7

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 IZQ

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