Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled 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 Owandy with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 28, 2014: OPTEO, VIDEOGRAPH HD.
| Apr 28, 2014 | OPTEO, VIDEOGRAPH HDK133271 · MUH | 510(k) clearances |
| Jun 14, 2013 | I-MAX TOUCH 3DK130443 · OAS | 510(k) clearances |
| Oct 18, 2010 | VISTEOK093105 · EHD | 510(k) clearances |
| Jun 2, 2009 | I-MAX TOUCHK083057 · MUH | 510(k) clearances |
| Apr 5, 2007 | KRYSTAL-X WIFIK070505 · MUH | 510(k) clearances |
| Nov 14, 2006 | IMAX CEPH DIGITAL X-RAY SENSORK062403 · MUH | 510(k) clearances |
| Jun 9, 2006 | UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)K053172 · 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
