EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES— 510(k) K062171

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K062171 for EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES, Substantially Equivalent on 2007-05-25. Applicant: Ortho Development Corp..

Clearance details

Applicant: Ortho Development Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-07-31
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.