ulrichINJECT CT Motion (XD 8000)— 510(k) K251295
Substantially EquivalentUlrich GmbH & Co. KG
FDA 510(k) clearance K251295 for ulrichINJECT CT Motion (XD 8000), Substantially Equivalent on 2025-11-07. Applicant: Ulrich GmbH & Co. KG.
Clearance details
- Applicant
- Ulrich GmbH & Co. KG
- Product code
- Code IZQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.