DeviceClearance

K090819

Substantially Equivalent

ONTEX TAMPON (UNSCENTED)

Applicant
Ontex International NV
Product code
HEB
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Austin, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HEB

product code HEB
Injury
329
Malfunction
5,647
Total
5,976

Source: openFDA MAUDE database, through . 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.