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Dymedix Diagnostics, Inc.

FDA Regulatory Profile

Dymedix Diagnostics, Inc. has 0 FDA recalls, 4 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 11, 2026 · NAI
Latest 510(k)
Jul 22, 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
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 11, 2026Shoreview, MNDevicesNo Action Indicated (NAI)3009351773
Oct 14, 2021Shoreview, MNDevicesNo Action Indicated (NAI)3009351773
Jul 7, 2016Shoreview, MNDevicesNo Action Indicated (NAI)3009351773
Aug 2, 2012Shoreview, MNDevicesNo Action Indicated (NAI)3009351773

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
K200654Rubicon SA SystemJul 22, 2020
K192564Disposable Gold Cup EEG ElectrodesJan 21, 2020

FDA data resources