Cowellmedi Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Cowellmedi Co., Ltd.” (first 2004, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 210 days. Since 2017 the median was 248 days, against 191 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 141 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 617 |
| 2023 | 4 | 187 |
| 2024 | 1 | 248 |
| 2025 | 1 | 410 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cowellmedi Co., Ltd. took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
Review panels
- Dental (14)
Most recent Cowellmedi Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242287 | SFIT Abutment | NHA | 2025-09-16 | 410 |
| K241127 | INNO SLA Mini Plus® Implant System | DZE | 2024-12-27 | 248 |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | NHA | 2023-12-20 | 218 |
| K232546 | Meta G UCLA Abutment | NHA | 2023-11-21 | 90 |
| K231395 | INNO SLA Submerged Narrow Implant System | DZE | 2023-10-18 | 156 |
| K211554 | InnoGenic Non-resorbable Membrane | NPK | 2023-02-24 | 646 |
| K201323 | INNO SLA Submerged Implant System | NHA | 2022-01-25 | 617 |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | DZE | 2013-12-06 | 141 |
| K100850 | COWELL IMPLANT SYSTEM | DZE | 2010-12-20 | 269 |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | DZE | 2009-07-29 | 202 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cowellmedi Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cowellmedi Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Cowellmedi Co., Ltd.” (first 2004, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cowellmedi Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cowellmedi Co., Ltd. is 210 days. Since 2017: 248 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cowellmedi Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 9); NHA (Abutment, Implant, Dental, Endosseous, 4); NPK (Barrier, Synthetic, Intraoral, 1).
Next steps
- See all 14 Cowellmedi Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Cowellmedi Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.