K252281

Substantially Equivalent

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

Applicant: Ulrich GmbH & Co. KG
Product code: IZQ
Advisory panel: Cardiovascular
Date received: 2025-07-22
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ulm, DE

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

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 →

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