K071180

Substantially Equivalent

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

Applicant: Engineered Medical Solutions Co., LLC
Product code: FTD
Advisory panel: General, Plastic Surgery
Date received: 2007-04-30
Decision date: 2007-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leola, PA, US

Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.