DERMAVBLADE(TM)— 510(k) K945430

Substantially Equivalent

Hasting'S Biomedical Corp.

FDA 510(k) clearance K945430 for DERMAVBLADE(TM), Substantially Equivalent on 1994-11-28. Applicant: Hasting'S Biomedical Corp..

Clearance details

Applicant: Hasting'S Biomedical Corp.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1994-08-23
Decision date: 1994-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quincy, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.