Fmi Medical Systems, Inc.

FDA Regulatory Profile

Fmi Medical Systems, Inc. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Mar 5, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K192590CURA 778Mar 5, 2020
K173076CURA 16; ScintCare CT16Oct 4, 2018