Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SpainLabelled 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 Sedecal and its 1 subsidiaries with 58 device recalls, 29 510(k) clearances and 1 warning letter. The most recent is a warning letter dated May 5, 2025: Warning letter: CAPA, Complaint handling, Design controls.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sedecal and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 5, 2025 | Warning letter: CAPA, Complaint handling, Design controlsCDRH | Warning letters |
| Aug 21, 2023 | SM-IVK232185 · IZL | 510(k) clearances |
| Nov 21, 2022 | SM-VK222951 · IZL | 510(k) clearances |
| Jul 18, 2022 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.K221803 · IZL | 510(k) clearances |
| Sep 14, 2021 | PHOENIXK212291 · IZL | 510(k) clearances |
| Feb 1, 2021 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsK203537 · KPR | 510(k) clearances |
| Oct 7, 2020 | Radiographic System Challenge XK202293 · KPR | 510(k) clearances |
| Nov 15, 2019 | Soltus 500K192936 · IZL | 510(k) clearances |
| Sep 25, 2019 | PhoeniXK192011 · IZL | 510(k) clearances |
| Mar 23, 2015 | Sedecal SA Mobile Diagnost w DR x-ray systemClass II · Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient | Device recalls |
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
