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Cardiomedix, Inc.

FDA Regulatory Profile

Cardiomedix, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jul 16, 2021 · VAI
Latest 510(k)
Oct 18, 2017

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 16, 2021Des Plaines, ILDevicesVoluntary Action Indicated (VAI)1000326503

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K172801ECG SENTINEL SystemOct 18, 2017

FDA data resources