K003423

Substantially Equivalent

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

Applicant: St. Francis Medical Equipment Co., Ltd.
Product code: FTD
Advisory panel: General, Plastic Surgery
Date received: 2000-11-03
Decision date: 2001-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Shien, Taiwan, R.O.C., TW

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.