Cowellmedi Co., Ltd.
Busan, KR
COWELLMEDI CO., LTD. appears in FDA device records in Busan, KR. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Cowellmedi Co., Ltd. between 2004 and 2025. The busiest year on record is 2023, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242287 | SFIT Abutment | NHA | Substantially Equivalent | |
| K241127 | INNO SLA Mini Plus® Implant System | DZE | Substantially Equivalent | |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | NHA | Substantially Equivalent | |
| K232546 | Meta G UCLA Abutment | NHA | Substantially Equivalent | |
| K231395 | INNO SLA Submerged Narrow Implant System | DZE | Substantially Equivalent | |
| K211554 | InnoGenic Non-resorbable Membrane | NPK | Substantially Equivalent | |
| K201323 | INNO SLA Submerged Implant System | NHA | Substantially Equivalent | |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K100850 | COWELL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | DZE | Substantially Equivalent | |
| K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | DZE | Substantially Equivalent | |
| K071148 | ATLAS IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K050635 | ALLFIM IMPLANT SYSTEMS | DZE | Substantially Equivalent | |
| K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005115116 | 3005115116 | COWELLMEDI CO., LTD. | 48, Hakgam-daero 221beon-gil, BUSAN 46986 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain