Xeridiem Medical Devices

FDA Regulatory Profile

Xeridiem Medical Devices has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 7, 2020 · VAI
Latest 510(k)
Jun 6, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 7, 2020Tucson, AZDevicesVoluntary Action Indicated (VAI)2025851
Jul 24, 2013Tucson, AZDevicesVoluntary Action Indicated (VAI)2025851

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
K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR…Jun 6, 2017
K130674ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBEJan 13, 2014
K130611ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBEDec 19, 2013