XLR8 PLUS (XLR8+)— 510(k) K141437

Substantially Equivalent

Genadyne Biotechnologies, Inc.

FDA 510(k) clearance K141437 for XLR8 PLUS (XLR8+), Substantially Equivalent on 2014-09-19. Applicant: Genadyne Biotechnologies, Inc..

Clearance details

Applicant: Genadyne Biotechnologies, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2014-05-30
Decision date: 2014-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hicksville, NY, US

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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.