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Trutek Corp

FDA Regulatory Profile

Trutek Corp has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 18, 2024 · VAI
Latest 510(k)
Feb 22, 2006

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 18, 2024Bridgewater, NJDevicesVoluntary Action Indicated (VAI)3008653514

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
K053625NASALGUARDFeb 22, 2006
K023510TRUTEK SELECT MODEL TT-1001Feb 4, 2003

FDA data resources