Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Digimed Co., Ltd. with 7 510(k) clearances and 1 device recall. The most recent is a device recall dated Jun 19, 2025: Portable X-ray system.
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.
| Date | Record | Source |
|---|---|---|
| Jun 19, 2025 | Portable X-ray systemClass II · Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. | Device recalls |
| Mar 3, 2023 | DHX-70H, XTG-70HK221587 · EHD | 510(k) clearances |
| Sep 1, 2022 | Hybrid C70K220579 · EHD | 510(k) clearances |
| Apr 22, 2022 | HYBRID S70K220574 · EHD | 510(k) clearances |
| Aug 10, 2018 | Portable X-ray System (Model: MiniX-V, Mini X-S)K181891 · EHD | 510(k) clearances |
| Dec 3, 2015 | Portable X-ray System (Model: MINIX-V / MINIX-S)K152859 · EHD | 510(k) clearances |
| Apr 8, 2011 | PORTABLE X-RAY SYSTEMK103600 · EHD | 510(k) clearances |
| Sep 26, 2008 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROXK082167 · EHD | 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
