XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and— 510(k) K142646

Substantially Equivalent

Genadyne Biotechnologies, Inc.

FDA 510(k) clearance K142646 for XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, Substantially Equivalent on 2015-04-30. Applicant: Genadyne Biotechnologies, Inc..

Clearance details

Applicant: Genadyne Biotechnologies, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2014-09-17
Decision date: 2015-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.