K041690

Substantially Equivalent

MONARCH NASAL IMPLANT

Applicant: Hanson Medical, Inc.
Product code: FZE
Advisory panel: General, Plastic Surgery
Date received: 2004-06-22
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, WA, US

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.