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Medbio, LLC

FDA Regulatory Profile

Medbio, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Aug 22, 2016 · NAI
Latest 510(k)
Sep 12, 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
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 22, 2016Grand Rapids, MIDevicesNo Action Indicated (NAI)3009810261
Jan 23, 2015Grand Rapids, MIDevicesNo Action Indicated (NAI)3009810261

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
K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelSep 12, 2017

FDA data resources