Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Dexcowin Co., Ltd. with 5 510(k) clearances and 3 warning letters. The most recent is a warning letter dated Oct 25, 2023: Warning letter: Medical Devices.
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.
| Oct 25, 2023 | Warning letter: Medical DevicesCDRH | Warning letters |
| Feb 20, 2018 | Warning letter: Process validation, CAPA, MDR reportingCDRH | Warning letters |
| Oct 26, 2017 | Cocoon Portable Handheld X-Ray SystemK173046 · MUH | 510(k) clearances |
| Oct 5, 2015 | ADX6000 Portable X-Ray System; iRayA6K143494 · IZL | 510(k) clearances |
| Aug 11, 2015 | Warning letter: Complaint handling, MDR reporting, 510(k) requiredCDRH | Warning letters |
| May 9, 2014 | ADX4000WK134055 · MUH | 510(k) clearances |
| Apr 24, 2014 | DX3000-LK133007 · MUH | 510(k) clearances |
| Mar 10, 2009 | ADX4000-L, DX3000-LK083532 · MUH | 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
