U Deliver Medical, LLC

FDA Regulatory Profile

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

Latest inspection
Jan 15, 2025 · NAI
Latest 510(k)
May 31, 2019

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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 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 15, 2025Hopkins, MNDevicesNo Action Indicated (NAI)3014016859
Apr 19, 2022Hopkins, MNDevicesVoluntary Action Indicated (VAI)3014016859
Oct 10, 2018Hopkins, MNDevicesNo Action Indicated (NAI)3014016859

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
K190310U Deliver Bolink ENFit Enteral Feeding SetsMay 31, 2019
K170555U Deliver Bolink ENFit Enteral Feeding SetsAug 17, 2017