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Anatomage, Inc.

FDA Regulatory Profile

Anatomage, Inc. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 7, 2014 · VAI
Latest 510(k)
Sep 21, 2018

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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) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 7, 2014Santa Clara, CADevicesVoluntary Action Indicated (VAI)3008272529

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
K181926InVivo Web ViewerSep 21, 2018
K161270CephSimulationJan 4, 2017
K150976CollageJun 4, 2015
K140093TABLEMar 7, 2014
K123519INVIVO DENTALFeb 1, 2013
K070803INVIVODENTALApr 6, 2007

FDA data resources