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Tecnimed S.R.L.

FDA Regulatory Profile

Tecnimed S.R.L. has 0 FDA recalls, 2 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 5, 2018 · NAI
Latest 510(k)
Apr 19, 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) clearances5Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 5, 2018Vedano Olona, ItalyDevicesNo Action Indicated (NAI)3003334361
Nov 30, 2011Vedano Olona, ItalyDevicesNo Action Indicated (NAI)3003334361

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
K160680VisioFocus Mini, VisioFocus SmartApr 19, 2017
DEN130019ZANZA-CLICKNov 7, 2014
K122412VISIOFOCUSMar 13, 2013
K072108MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIESAug 31, 2007
K033790THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIESJun 3, 2004

FDA data resources