Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SedecalLabelled 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 15, 2026, FDA's public records list Sedecal USA with 3 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 23, 2015: Sedecal SA Mobile Diagnost w DR x-ray system.
| 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 |
| Sep 29, 2004 | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 DK042361 · IZL | 510(k) clearances |
| Nov 2, 2001 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEMK012546 · KPR | 510(k) clearances |
| Aug 31, 2001 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)K012663 · IZL | 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
