DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Heraeus Instruments GmbH
Product code
Code FTD
Device class
Class 2
Regulation
21 CFR 878.4580
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hanau, DE
Download summary PDFView on FDA.gov ↗

Recent devices under product code FTD

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Adverse events under product code FTD

product code FTD
Malfunction
767
Total
767

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K932451

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932451.

Data sourced from openFDA. This site is unofficial and independent of the FDA.