TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA— 510(k) K091281

Substantially Equivalent

Procter & Gamble Co.

FDA 510(k) clearance K091281 for TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA, Substantially Equivalent on 2010-06-01. Applicant: Procter & Gamble Co..

Clearance details

Applicant: Procter & Gamble Co.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2009-05-01
Decision date: 2010-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.