Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Ontex GroupLabelled 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 13, 2026, FDA's public records list Ontex Bvba with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 20, 2019: Unscented W long plastic and cardboard applicator tampons.
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.
| Date | Record | Source |
|---|---|---|
| Dec 20, 2019 | Unscented W long plastic and cardboard applicator tamponsK191666 · HEB | 510(k) clearances |
| Mar 3, 2017 | Ontex and other proprietary namesK162746 · HEB | 510(k) clearances |
| Jun 23, 2015 | Ontex Unscented Tampons with Colored Plastic ApplicatorsK142786 · HEB | 510(k) clearances |
| Apr 23, 2014 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSK132595 · HEB | 510(k) clearances |
| Apr 10, 2014 | ONTEX AND OTHERS PROPRIETARY NAMESK132208 · HIL | 510(k) clearances |
| Dec 19, 2012 | ONTEX AND OTHER PROPRIETARY NAMESK122603 · HEB | 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
