ONTEX TAMPON (UNSCENTED)— 510(k) K090819

Substantially Equivalent

Ontex International NV

FDA 510(k) clearance K090819 for ONTEX TAMPON (UNSCENTED), Substantially Equivalent on 2009-12-23. Applicant: Ontex International NV.

Clearance details

Applicant: Ontex International NV
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2009-03-25
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Austin, TX, US

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.