Medtronic Care Management Services

FDA Regulatory Profile

Medtronic Care Management Services has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 1, 2024 · NAI
Latest 510(k)
May 15, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 1, 2024Lafayette, CODevicesNo Action Indicated (NAI)3004594267
Jul 20, 2015Lafayette, CODevicesNo Action Indicated (NAI)3004594267
Jul 25, 2012Lafayette, CODevicesNo Action Indicated (NAI)3004594267

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
K191745Medtronic Commander FlexMay 15, 2020