Medical Device Manufacturer · US , Cincinnati , OH

Procter & Gamble Co. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1988
23
Total
23
Cleared
0
Denied

Procter & Gamble, Co. is a consumer health and personal care company headquartered in Cincinnati, US. The company develops and markets a broad range of health and wellness products globally.

Procter & Gamble has received 23 FDA 510(k) clearances from 23 total submissions, with no denied submissions on record. The company's regulatory focus has centered on Obstetrics & Gynecology devices, which represent the dominant category of its submissions. FDA 510(k) clearances span from 1988 to 2014, establishing a historical regulatory record in feminine care and oral health device categories.

Notable cleared devices include tampon products across multiple absorbency levels and applicator designs, as well as dental care products such as powered toothbrushes and clinical floss. These products reflect the company's core expertise in personal hygiene and women's health.

This profile represents a historical regulatory record. For detailed information on specific device names, product codes, and individual clearance dates, explore the full submission history.

Procter & Gamble Co. — FDA 510(k) Products and Clearance History

23 devices
1-23 of 23
Cleared Sep 15, 2014
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER...
K141018 · JEQ
Dental · 147d
Cleared Jun 20, 2013
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · HEB
Obstetrics & Gynecology · 22d
Cleared Jun 01, 2010
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX...
K091281 · HEB
Obstetrics & Gynecology · 396d
Cleared Sep 24, 2009
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K091964 · JES
Dental · 85d
Cleared Jun 27, 2008
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
K081555 · HIL
Obstetrics & Gynecology · 24d
Cleared Nov 22, 2006
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K062638 · HEB
Obstetrics & Gynecology · 78d
Cleared Aug 01, 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K061486 · HEB
Obstetrics & Gynecology · 62d
Cleared Dec 27, 2005
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND...
K051290 · HEB
Obstetrics & Gynecology · 223d
Cleared Jul 09, 2004
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · HEB
Obstetrics & Gynecology · 81d
Cleared May 03, 2004
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · HIL
Obstetrics & Gynecology · 84d
Cleared Oct 05, 2001
ALWAYS DUETS
K012629 · HHD
Obstetrics & Gynecology · 53d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · HIL
Obstetrics & Gynecology · 84d
Cleared Jul 02, 2001
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
K011171 · HIL
Obstetrics & Gynecology · 76d
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · HHD
Obstetrics & Gynecology · 58d
Cleared Sep 08, 2000
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · HEB
Obstetrics & Gynecology · 59d
Cleared Jan 18, 2000
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · HHD
Obstetrics & Gynecology · 64d
Cleared Mar 11, 1998
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · EFW
Dental · 195d
Cleared Nov 30, 1994
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
K945200 · KOO
Dental · 36d
Cleared Feb 02, 1993
ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
K922575 · HHD
Obstetrics & Gynecology · 246d
Cleared Sep 23, 1991
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
K913237 · HHL
Obstetrics & Gynecology · 63d
Cleared Sep 23, 1991
ALWAYS, UNSCENTED MENSTRUAL PAD
K913238 · HHL
Obstetrics & Gynecology · 63d
Cleared Dec 02, 1988
ALWAYS UNSCENTED MENSTRUAL PADS
K884428 · HHD
Obstetrics & Gynecology · 43d
Cleared Dec 02, 1988
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
K884429 · HHL
Obstetrics & Gynecology · 43d
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