AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM— 510(k) K013242

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K013242 for AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM, Substantially Equivalent on 2001-12-13. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 2001-09-28
Decision date: 2001-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Montgomery, AL, US

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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.