Data / Medical devices / United States / Procter & Gamble Co.

Procter & Gamble Co.: FDA-registered device maker in Cincinnati, OH, United States, 5 510(k) clearances

Name: Procter & Gamble Co. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Procter & Gamble Co. is registered with the FDA (registration 1523399) in Cincinnati, OH, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 9, 2014. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1523399
Address: 6280 Center Hill Ave, Cincinnati, OH, United States, 45224
Owner or operator: Procter & Gamble (9915005)
Roles: Complaint file establishment, Specification developer
First device listed: November 26, 1986
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cup, Menstrual	HHE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Menstrual, Reusable	NUQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	NRC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 9, 2014	K133244	TAMPAX M PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Company	accessdata.fda.gov
June 20, 2013	K131543	TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
June 2, 2011	K110669	TAMPAX C PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Co.	accessdata.fda.gov
June 27, 2008	K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
August 1, 2006	K061486	TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov

Compare with other makers

Updated January 9, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.