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Biotem Co., Ltd.

FDA Regulatory Profile

Biotem Co., Ltd. has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jun 24, 2023

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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
Inspections0Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K222142BR SLA Type Implant SystemJun 24, 2023
K222144IR SLA Type Implant SystemJun 14, 2023
K190641AR_N SLA Type Implant SystemFeb 21, 2020
K171179BR Type Implant SystemFeb 9, 2018
K171297AR_N Type Implant SystemJan 31, 2018
K171185IR Type Implant SystemDec 1, 2017

FDA data resources