HealiAid Dental Collagen Wound Dressing— 510(k) K230529

Substantially Equivalent

Maxigen Biotech, Inc.

FDA 510(k) clearance K230529 for HealiAid Dental Collagen Wound Dressing, Substantially Equivalent on 2023-11-22. Applicant: Maxigen Biotech, Inc..

Clearance details

Applicant: Maxigen Biotech, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2023-02-27
Decision date: 2023-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.