Toul Meditech AB

FDA Regulatory Profile

Toul Meditech AB has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 27, 2025 · VAI
Latest 510(k)
May 10, 2019

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 27, 2025Vasteras, SwedenDevicesVoluntary Action Indicated (VAI)3012992602

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
K190027SteriStayMay 10, 2019
K173349OperioDec 20, 2017
K153498OperioJul 20, 2016