510(k) Report

FDA applicant

Procter & Gamble Co.

Cincinnati, OH33 decisions1988–20213 recalls

FDA records 33 decisions for Procter & Gamble Co. (Cincinnati, OH) from 1988 to 2021: 33 510(k) clearances. Most are in product codes HEB (Tampon, Menstrual, Unscented) and HHD (Pad, Menstrual, Unscented). Its devices cite 30 predicates, 18 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “The Procter & Gamble Company”, “Procter & Gamble”, “The Procter & Gamble Co.”, “Procter & Gamble, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Procter & Gamble Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12008: 22009: 22010: 12011: 12012: 12013: 12014: 22015: 12020: 22021: 1
2007high 2 (2008) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12023: 12025: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Procter & Gamble Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Procter”

FDA records each applicant name separately; these may or may not be the same firm.