FDA Product Code
FDA Product Code HEB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5470
510(k) Clearances — 189 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | 2026-03-20 | Traditional | PDF ↗ |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 | Special | PDF ↗ |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | 2025-10-09 | Special | PDF ↗ |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 | Special | PDF ↗ |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 | Special | PDF ↗ |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 | Traditional | PDF ↗ |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 | Traditional | PDF ↗ |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | 2024-04-12 | Traditional | PDF ↗ |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023-12-15 | Traditional | PDF ↗ |
| K223883 | Daye Tampon | Annes Daye, Ltd. | 2023-08-18 | Traditional | PDF ↗ |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 | Traditional | PDF ↗ |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | 2023-08-03 | Traditional | PDF ↗ |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023-01-06 | Traditional | PDF ↗ |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K212277 | Tempo Tampon | Dong-A Pharmaceutical Co., Ltd. | 2022-04-21 | Traditional | PDF ↗ |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022-02-25 | Special | PDF ↗ |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021-10-22 | Traditional | PDF ↗ |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | 2021-10-08 | Traditional | PDF ↗ |
| K212272 | Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. | 2021-09-17 | Traditional | PDF ↗ |
| K212304 | Callaly Tampliner (super plus absorbency) | Calla Lily Personal Care, Ltd. | 2021-08-19 | Special | PDF ↗ |
| K211519 | Every Cycle Reusable Tampon Applicator | Cycle, LLC | 2021-08-13 | Traditional | PDF ↗ |
| K211469 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2021-06-10 | Special | PDF ↗ |
| K201003 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | 2020-02-13 | Special | PDF ↗ |
| K191666 | Unscented W long plastic and cardboard applicator tampons | Ontex Bvba | 2019-12-20 | Traditional | PDF ↗ |
| K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | 2019-10-07 | Traditional | PDF ↗ |
| K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | 2019-08-28 | Traditional | PDF ↗ |
| K182817 | CottonDay Tampon | Taebong Co., Ltd. | 2019-07-22 | Traditional | PDF ↗ |
| K182814 | Rael Tampon | Rael, Inc. | 2019-07-15 | Traditional | PDF ↗ |
| K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | 2019-05-09 | Traditional | PDF ↗ |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Cotton High Tech S.L. | 2019-03-15 | Special | PDF ↗ |
| K181911 | Interlude 100% Cotton Tampon | Albaad Fem | 2018-11-02 | Traditional | PDF ↗ |
| K180850 | re.t.a Reuseable Tampon Applicator | Thinx, Inc. | 2018-08-20 | Traditional | PDF ↗ |
| K173225 | Interlude and private label Unscented 3-piece compact applicator tampon | Albaad Fem | 2018-06-15 | Traditional | PDF ↗ |
| K180167 | Playtex Stella Tampons | Playtex Manufacturing, Inc. | 2018-05-30 | Traditional | PDF ↗ |
| K172504 | Tosama Biobased Applicator Tube Menstrual Tampon | Tosama, D.O.O. | 2018-02-09 | Traditional | PDF ↗ |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2017-10-11 | Traditional | PDF ↗ |
| K162746 | Ontex and other proprietary names | Ontex Bvba | 2017-03-03 | Traditional | PDF ↗ |
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl | First Quality Hygienic, Inc. | 2016-08-05 | Special | PDF ↗ |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | Cotton High Tech S.L. | 2015-12-04 | Traditional | PDF ↗ |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency | First Quality Hygienic, Inc. | 2015-11-02 | Abbreviated | PDF ↗ |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-07-02 | Traditional | PDF ↗ |
| K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015-06-23 | Traditional | PDF ↗ |
| K150897 | Tosama 100% Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-04-20 | Traditional | PDF ↗ |
| K140077 | ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED | Albaad , Ltd. | 2014-09-22 | Traditional | PDF ↗ |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | Kimberly-Clark Corp. | 2014-08-25 | Traditional | PDF ↗ |
| K132595 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS | Ontex Bvba | 2014-04-23 | Traditional | PDF ↗ |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | The Procter & Gamble Company | 2014-01-09 | Special | PDF ↗ |
| K131543 | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | Procter & Gamble Co. | 2013-06-20 | Special | PDF ↗ |
| K130609 | VEEDA 100% COTTON MENSTRUAL TAMPON | Naturalena Brands, Inc. | 2013-03-21 | Traditional | PDF ↗ |
| K122603 | ONTEX AND OTHER PROPRIETARY NAMES | Ontex Bvba | 2012-12-19 | Traditional | PDF ↗ |
| K120481 | LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, | Tosama, D.O.O. | 2012-07-13 | Special | PDF ↗ |
| K113699 | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | The Procter & Gamble Company | 2012-01-12 | Special | PDF ↗ |
| K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | Kimberly-Clark Corporation | 2011-11-02 | Special | PDF ↗ |
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | Kimberly-Clark Corp. | 2011-10-07 | Special | PDF ↗ |
| K110669 | TAMPAX C PLASTIC TAMPONS, UNSCENTED | The Procter & Gamble Co. | 2011-06-02 | Special | PDF ↗ |
| K103311 | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS | Kimberly Clark Corporation | 2010-12-10 | Special | PDF ↗ |
| K102445 | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2010-11-10 | Traditional | PDF ↗ |
| K091281 | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA | Procter & Gamble Co. | 2010-06-01 | Traditional | PDF ↗ |
| K090819 | ONTEX TAMPON (UNSCENTED) | Ontex International NV | 2009-12-23 | Abbreviated | PDF ↗ |
| K091749 | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS | Kimberly-Clark Corp. | 2009-12-23 | Traditional | PDF ↗ |
| K092054 | MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON | Tosama D.D. | 2009-07-29 | Special | PDF ↗ |
| K090071 | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2009-05-28 | Traditional | PDF ↗ |
| K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | Cotton High Tech S.L. | 2009-04-29 | Traditional | PDF ↗ |
| K080733 | COTTONS 100% NATURAL COTTON TAMPONS | Cottons Pty, Ltd. | 2009-02-18 | Abbreviated | PDF ↗ |
| K090098 | MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON | Maxim Hygiene Products, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K080775 | MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS | Tosama D.D. | 2008-09-10 | Traditional | PDF ↗ |
| K062001 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2006-12-07 | Traditional | PDF ↗ |
| K062638 | TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS | Procter & Gamble Co. | 2006-11-22 | Traditional | PDF ↗ |
| K061486 | TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) | Procter & Gamble Co. | 2006-08-01 | Traditional | PDF ↗ |
| K051290 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) | Procter & Gamble Co. | 2005-12-27 | Traditional | PDF ↗ |
| K050660 | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2005-05-12 | Traditional | PDF ↗ |
| K040999 | TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) | Procter & Gamble Co. | 2004-07-09 | Traditional | PDF ↗ |
| K030474 | PH BUFFERING PLASTIC APPLICATOR TAMPON | Rostam , Ltd. | 2004-05-28 | Traditional | PDF ↗ |
| K032636 | PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) | Playtex Products, Inc. | 2003-11-14 | Traditional | PDF ↗ |
| K031067 | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS | First Quality Hygienic, Inc. | 2003-07-14 | Traditional | PDF ↗ |
| K023789 | O.B. TAMPONS | Mcneil-Ppc, Inc. | 2002-12-06 | Special | PDF ↗ |
| K023479 | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES | First Quality Hygienic, Inc. | 2002-11-26 | Traditional | PDF ↗ |
| K020535 | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2002-05-09 | Traditional | PDF ↗ |
| K992493 | VIPON TAMPON | Another Way Products, LLC | 2000-11-06 | Traditional | PDF ↗ |
| K002096 | TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR | Procter & Gamble Co. | 2000-09-08 | Traditional | PDF ↗ |
| K001641 | TAMPONS | Rostam , Ltd. | 2000-08-03 | Traditional | PDF ↗ |
| K993794 | PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS | Playtime Products, Inc. | 2000-02-07 | Traditional | PDF ↗ |
| K990536 | O.B. TAMPON | Personal Products Co. | 1999-08-31 | Traditional | PDF ↗ |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Personal Products Co. | 1999-06-29 | Traditional | PDF ↗ |
| K983478 | ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON | Organic Essentials | 1998-11-09 | Traditional | PDF ↗ |
| K983381 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | Paragon Trade Brands, Inc. | 1998-10-19 | Traditional | PDF ↗ |
| K981953 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | Paragon Trade Brands, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K981760 | PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 | Playtime Products, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K980478 | PLAYTEX TAMPONS #03498 | Playtex, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Personal Products Co. | 1998-02-10 | Traditional | PDF ↗ |
| K970954 | O.B. APPLICATOR TAMPONS | Personal Products Co. | 1997-06-10 | Traditional | PDF ↗ |
| K971174 | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | Playtex, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K971228 | FEMTEX 100% COTTON TAMPONS | Regu-Tech Assoc., Inc. | 1997-04-09 | Traditional | PDF ↗ |
| K970108 | HARMONIES MENSTRUAL TAMPON | Ecoprogress Intl. | 1997-04-03 | Traditional | PDF ↗ |
| K970232 | FEMTEX 100% COTTON DENTLE TOUCH TAMPONS | Regu-Tech Assoc., Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K965064 | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON | Rostam , Ltd. | 1997-02-20 | Traditional | PDF ↗ |
| K963034 | FEMTEX GENTLE TOUCH TAMPONS | First Quality Hygienic, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K963032 | FREE CHOICE | First Quality Hygienic, Inc. | 1996-10-11 | Traditional | PDF ↗ |
Product code HEB · Class II · Obstetrics/Gynecology. Data: openFDA.