510(k) K032303— STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Substantially Equivalent

Stryker Instruments

Clearance details

Applicant: Stryker Instruments
Product code: Code HBE
Advisory panel: Neurology
Date received: 2003-07-25
Decision date: 2004-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.