MDT/CASTLE 2000 SURGICAL LIGHTS— 510(k) K914076

Substantially Equivalent

Mdt Corp., Inc.

FDA 510(k) clearance K914076 for MDT/CASTLE 2000 SURGICAL LIGHTS, Substantially Equivalent on 1991-11-13. Applicant: Mdt Corp., Inc..

Clearance details

Applicant: Mdt Corp., Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1991-09-11
Decision date: 1991-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.