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Fuji Systems Corporation

FDA Regulatory Profile

Fuji Systems Corporation has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 27, 2015 · NAI
Latest 510(k)
Dec 9, 2022

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 27, 2015Nishishirakawa-Gun, JapanDevicesNo Action Indicated (NAI)3000308637
Apr 29, 2010Nishishirakawa-Gun, JapanDevicesNo Action Indicated (NAI)3000308637

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
K223275CELLO II Balloon Guide CatheterDec 9, 2022
K120781CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTHAug 9, 2012
K051522SILBRONCHO DOUBLE LUMEN TUBEAug 17, 2005

FDA data resources