Biotem Co., Ltd.

FDA Regulatory Profile

Biotem Co., Ltd. appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 24, 2023.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K222142BR SLA Type Implant SystemJune 24, 2023
K222144IR SLA Type Implant SystemJune 14, 2023
K190641AR_N SLA Type Implant SystemFebruary 21, 2020
K171179BR Type Implant SystemFebruary 9, 2018
K171297AR_N Type Implant SystemJanuary 31, 2018
K171185IR Type Implant SystemDecember 1, 2017