Company · US
Cowellmedi Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2025 | K242287 | SFIT Abutment Cowellmedi Co., Ltd., KR | NHA |
| Dec 27, 2024 | K241127 | INNO SLA Mini Plus® Implant System Cowellmedi Co., Ltd., KR | DZE |
| Dec 20, 2023 | K231411 | INNO SLA Submerged Hybrid Ti-Base System Cowellmedi Co., Ltd., KR | NHA |
| Nov 21, 2023 | K232546 | Meta G UCLA Abutment Cowellmedi Co., Ltd., KR | NHA |
| Oct 18, 2023 | K231395 | INNO SLA Submerged Narrow Implant System Cowellmedi Co., Ltd., KR | DZE |
| Feb 24, 2023 | K211554 | InnoGenic Non-resorbable Membrane Cowellmedi Co., Ltd., KR | NPK |
| Jan 25, 2022 | K201323 | INNO SLA Submerged Implant System Cowellmedi Co., Ltd., KR | NHA |
| Dec 6, 2013 | K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM Cowellmedi Co., Ltd. | DZE |
| Dec 20, 2010 | K100850 | COWELL IMPLANT SYSTEM Cowellmedi Co., Ltd. | DZE |
| Jul 29, 2009 | K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS Cowellmedi Co., Ltd. | DZE |
| Apr 20, 2009 | K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS Cowellmedi Co., Ltd. | DZE |
| Feb 6, 2008 | K071148 | ATLAS IMPLANT SYSTEM Cowellmedi Co., Ltd. | DZE |
| Jul 28, 2005 | K050635 | ALLFIM IMPLANT SYSTEMS Cowellmedi Co., Ltd. | DZE |
| Sep 8, 2004 | K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) Cowellmedi Co., Ltd. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||