Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biotem Co., Ltd. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jun 24, 2023: BR SLA Type Implant System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 24, 2023 | BR SLA Type Implant SystemK222142 · DZE | 510(k) clearances |
| Jun 14, 2023 | IR SLA Type Implant SystemK222144 · DZE | 510(k) clearances |
| Feb 21, 2020 | AR_N SLA Type Implant SystemK190641 · DZE | 510(k) clearances |
| Feb 9, 2018 | BR Type Implant SystemK171179 · DZE | 510(k) clearances |
| Jan 31, 2018 | AR_N Type Implant SystemK171297 · DZE | 510(k) clearances |
| Dec 1, 2017 | IR Type Implant SystemK171185 · DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
