ClearanceBrief
510(k) K251989 ยท NEU Marker, Radiographic, Implantable

VizMark Preloaded Tissue Marker Device (VM-0001)

ApplicantBreast-Med, Inc., Hopkins MN, US
DecisionSubstantially Equivalent, Dec 12, 2025
ReceivedJun 27, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251989

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.