Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Omnitron International with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 27, 1992: PULMOCATH INTRABRONCHIAL CATHETER.
| Nov 27, 1992 | PULMOCATH INTRABRONCHIAL CATHETERK901615 · JAQ | 510(k) clearances |
| Sep 21, 1992 | IR-192 IMPLANT -- MODIFICATIONK923130 · KXK | 510(k) clearances |
| May 29, 1992 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGEK920431 · JAQ | 510(k) clearances |
| Mar 6, 1992 | OMNITRON GYN APPLICATOR SYSTEMK913908 · JAQ | 510(k) clearances |
| Feb 27, 1992 | IR-192 IMPLANT, MODIFICATIONK915253 · IWA | 510(k) clearances |
| May 8, 1991 | OMNICATH IMPLANTED CATHETER AND DEPOTK911775 · KXK | 510(k) clearances |
| Aug 11, 1988 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATORK881665 · JAQ | 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
