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 15, 2026, FDA's public records list Cowellmedi Co., Ltd. with 14 510(k) clearances. The most recent is a 510(k) clearance dated Sep 16, 2025: SFIT Abutment.
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.
| Sep 16, 2025 | SFIT AbutmentK242287 · NHA | 510(k) clearances |
| Dec 27, 2024 | INNO SLA Mini Plus® Implant SystemK241127 · DZE | 510(k) clearances |
| Dec 20, 2023 | INNO SLA Submerged Hybrid Ti-Base SystemK231411 · NHA | 510(k) clearances |
| Nov 21, 2023 | Meta G UCLA AbutmentK232546 · NHA | 510(k) clearances |
| Oct 18, 2023 | INNO SLA Submerged Narrow Implant SystemK231395 · DZE | 510(k) clearances |
| Feb 24, 2023 | InnoGenic Non-resorbable MembraneK211554 · NPK | 510(k) clearances |
| Jan 25, 2022 | INNO SLA Submerged Implant SystemK201323 · NHA | 510(k) clearances |
| Dec 6, 2013 | INNO SLA SUBMERGED IMPLANT SYSTEMK132242 · 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
