K933431

Substantially Equivalent

ORTHOTRAC COAXIAL LASER

Applicant: Trac Medical, Inc.
Product code: OXO
Advisory panel: Radiology
Date received: 1993-07-14
Decision date: 1993-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raliegh, NC, US

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.