Company ยท BE
Ontex Bvba
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2019. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2019 | K191666 | Unscented W long plastic and cardboard applicator tampons Ontex Bvba, BE | HEB |
| Mar 3, 2017 | K162746 | Ontex and other proprietary names Ontex Bvba, BE | HEB |
| Jun 23, 2015 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators Ontex Bvba, BE | HEB |
| Apr 23, 2014 | K132595 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS Ontex Bvba, NL | HEB |
| Apr 10, 2014 | K132208 | ONTEX AND OTHERS PROPRIETARY NAMES Ontex Bvba, NL | HIL |
| Dec 19, 2012 | K122603 | ONTEX AND OTHER PROPRIETARY NAMES Ontex Bvba | HEB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||