# Ontex International NV

- Location (FDA's records): Austin, TX
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: HEB (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Maxim Hygiene Products, Inc.: 1 (https://510kreport.com/company/maxim-hygiene-products)

## Firms that cite its devices most
- Ontex Bvba: 2 (https://510kreport.com/company/ontex)
- Qingdao Youjia Hygiene Technology Co., Ltd.: 1 (https://510kreport.com/company/qingdao-youjia-hygiene-technology)

## Its most-cited devices
- K090819: Ontex Tampon (Unscented) (2009), cited by 3

## Recent decisions
- K090819: Ontex Tampon (Unscented) (Dec 23, 2009)

Source page: https://510kreport.com/company/ontex-international