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Telemed

FDA Regulatory Profile

Telemed has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 16, 2023 · VAI
Latest 510(k)
Feb 11, 2022

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 16, 2023Vilnius, LithuaniaDevicesVoluntary Action Indicated (VAI)3007994837

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
K211248ArtUsFeb 11, 2022
K163121SmartUs EXT-1M/3MAug 10, 2017
K161968MicrUsNov 3, 2016
K113184LOGICSCAN 64 LOGICSCAN 128Jan 26, 2012
K102253ECHO BLASTERMar 14, 2011

FDA data resources