VizMark Preloaded Tissue Marker Device (VM-0001)— 510(k) K251989

Substantially Equivalent

Breast-Med, Inc.

FDA 510(k) clearance K251989 for VizMark Preloaded Tissue Marker Device (VM-0001), Substantially Equivalent on 2025-12-12. Applicant: Breast-Med, Inc..

Clearance details

Applicant: Breast-Med, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2025-06-27
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.