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Cellumed Co., Ltd.

FDA Regulatory Profile

Cellumed Co., Ltd. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Apr 10, 2014 · NAI
Latest 510(k)
Apr 11, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 10, 2014Seoul, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3006404440
May 13, 2010Seoul, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3006404440
Sep 18, 2009Seoul, Korea (The Republic Of)BiologicsVoluntary Action Indicated (VAI)3006404440

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
K180121Rafugen DBMApr 11, 2018

FDA data resources