Company ยท KR
Digimed Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2023 | K221587 | DHX-70H, XTG-70H Digimed Co., Ltd., KR | EHD |
| Sep 1, 2022 | K220579 | Hybrid C70 Digimed Co., Ltd., KR | EHD |
| Apr 22, 2022 | K220574 | HYBRID S70 Digimed Co., Ltd., KR | EHD |
| Aug 10, 2018 | K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., Ltd., KR | EHD |
| Apr 8, 2011 | K103600 | PORTABLE X-RAY SYSTEM Digimed Corporation | EHD |
| Sep 26, 2008 | K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX Digimed Corporation | EHD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | DIGIMED CO., LTD Portable X-ray system Open, Classified |
EHD | K082167 |