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Ashitaka Factory Of Terumo Corporation

FDA Regulatory Profile

Ashitaka Factory Of Terumo Corporation has 0 FDA recalls, 3 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 28, 2026 · NAI
Latest 510(k)
Mar 3, 2021

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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
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 28, 2026Fujinomiya, JapanDevicesNo Action Indicated (NAI)3002808327
Oct 31, 2018Fujinomiya, JapanDevicesNo Action Indicated (NAI)3002808327
Mar 5, 2015Fujinomiya, JapanDevicesNo Action Indicated (NAI)3002808327

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
K203521FineCross M3Mar 3, 2021
K170223ProgreatJul 21, 2017
K161546R2P SlenGuideOct 14, 2016
K152740Radifocus GlidewireNov 16, 2015
K150232Radifocus Optitorque Angiographic CatheterOct 19, 2015
K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRMar 13, 2013

FDA data resources