HANAULUX 2005 SURGICAL LIGHT— 510(k) K932451

Substantially Equivalent

Heraeus Instruments GmbH

FDA 510(k) clearance K932451 for HANAULUX 2005 SURGICAL LIGHT, Substantially Equivalent on 1993-11-12. Applicant: Heraeus Instruments GmbH.

Clearance details

Applicant: Heraeus Instruments GmbH
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 1993-05-20
Decision date: 1993-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanau, DE

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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.