Guidemia Technologies, LLC

FDA Regulatory Profile

Guidemia Technologies, LLC has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 6, 2026 · VAI
Latest 510(k)
Mar 24, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections3Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 6, 2026Buena Park, CADevicesVoluntary Action Indicated (VAI)3013634985
Feb 11, 2019Los Alamitos, CADevicesNo Action Indicated (NAI)3010052556
Dec 12, 2013Los Alamitos, CADevicesVoluntary Action Indicated (VAI)3010052556

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
K162850GuideMia Ortho+Mar 24, 2017
K121466GUIDEMIAMay 31, 2012