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Anzai Medical Co., Ltd.

FDA Regulatory Profile

Anzai Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 26, 2018 · NAI
Latest 510(k)
Apr 5, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 26, 2018Shinagawa, JapanDevicesNo Action Indicated (NAI)3008328959

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
K170719Anzai Respiratory Gating SystemApr 5, 2017
K160432Anzai Respiratory Gating SystemApr 22, 2016
K031385ANZAI AZ-733 RESPIRATORY GATING SYSTEMNov 10, 2003
K022342EZ-SCOPE AN, EZ-SCOPE LIGHTOct 9, 2002

FDA data resources