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Ue Lifesciences, Inc.

FDA Regulatory Profile

Ue Lifesciences, Inc. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 26, 2015 · VAI
Latest 510(k)
Jul 16, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 26, 2015Bohemia, NYDevicesVoluntary Action Indicated (VAI)3010251424
Aug 7, 2014Bohemia, NYDevicesNo Action Indicated (NAI)3010251424

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
K190575iBreastExamJul 16, 2019
K142926iBreastExamApr 23, 2015
K113259NOTOUCH BREASTSCANFeb 10, 2012

FDA data resources