K042793

Substantially Equivalent

ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)

Applicant: Siemens Medi Cal Solutions, Inc.
Product code: OWB
Advisory panel: Radiology
Date received: 2004-10-07
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, US

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.