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Monitex Industrial Co., Ltd.

FDA Regulatory Profile

Monitex Industrial Co., Ltd. has 0 FDA recalls, 1 inspection, 9 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 8, 2011 · VAI
Latest 510(k)
Nov 27, 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) clearances9Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2011Xin Bei Shi, TaiwanDevicesVoluntary Action Indicated (VAI)3003169405

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
K161855LED Curing LightNov 27, 2017
K152192LED Curing LightApr 7, 2017
K153078LED Curing Light GT-2000Jun 28, 2016
K150205LED Curing LightAug 24, 2015
K133040LED CURING LIGHTOct 7, 2014
K091887LED CURING LIGHT, MODEL GT-1500Sep 18, 2009
K080035LED CURING LIGHTMar 3, 2008
K060646BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855Apr 21, 2006
K051203BLUELEXMay 25, 2005

FDA data resources