K103418

Substantially Equivalent

DESARA MINI

Applicant: Caldera Medical, Inc.
Product code: PAH
Advisory panel: General, Plastic Surgery
Date received: 2010-11-22
Decision date: 2011-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Agoura Hills, CA, US

Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.