FDA 510(k) Applications for Medical Device Product Code "HEB"
(Tampon, Menstrual, Unscented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K181911 | ALBAAD fem | Interlude 100% Cotton Tampon | 11/02/2018 |
| K173225 | ALBAAD fem | Interlude and private label Unscented 3-piece compact applicator tampon | 06/15/2018 |
| K191431 | ALBAAD fem | Interlude Rolled Tampons in Plastic Applicator | 10/07/2019 |
| K140077 | ALBAAD LTD. | ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED | 09/22/2014 |
| K223883 | Annes Daye Ltd | Daye Tampon | 08/18/2023 |
| K992493 | ANOTHERWAY PRODUCTS LLC. | VIPON TAMPON | 11/06/2000 |
| K954942 | BODYWISE (UK), LTD. | NATRACAREN APPLICATOR TAMPON | 01/25/1996 |
| K211469 | Calla Lily Personal Care, Ltd. | Callaly Tampliner | 06/10/2021 |
| K201003 | Calla Lily Personal Care, Ltd. | Callaly Tampliner | 12/07/2020 |
| K212304 | Calla Lily Personal Care, Ltd. | Callaly Tampliner (super plus absorbency) | 08/19/2021 |
| K152284 | COTTON HIGH TECH S.L. | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | 12/04/2015 |
| K211775 | Cotton High Tech S.L. | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | 10/22/2021 |
| K212479 | Cotton High Tech S.L. | Cohitech Reusable Tampon Applicator | 10/08/2021 |
| K091084 | COTTON HIGH TECH SL | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | 04/29/2009 |
| K220238 | Cotton High Tech, S.L. | Cohitech Cottonlock Tampons with Reusable Applicator | 02/25/2022 |
| K182813 | Cotton High Tech, SL | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | 03/15/2019 |
| K080733 | COTTONS PTY, LTD | COTTONS 100% NATURAL COTTON TAMPONS | 02/18/2009 |
| K211519 | Cycle, LLC | Every Cycle Reusable Tampon Applicator | 08/13/2021 |
| K212272 | Dong-A Pharmaceutical Co., Ltd. | Tempo Natural Tampon | 09/17/2021 |
| K212277 | Dong-A Pharmaceutical Co., Ltd. | Tempo Tampon | 04/21/2022 |
| K970108 | ECOPROGRESS INTL. | HARMONIES MENSTRUAL TAMPON | 04/03/1997 |
| K050660 | FIRST QUALITY HYGIENIC, INC. | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | 05/12/2005 |
| K963034 | FIRST QUALITY HYGIENIC, INC. | FEMTEX GENTLE TOUCH TAMPONS | 11/01/1996 |
| K031067 | FIRST QUALITY HYGIENIC, INC. | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS | 07/14/2003 |
| K023479 | FIRST QUALITY HYGIENIC, INC. | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES | 11/26/2002 |
| K963032 | FIRST QUALITY HYGIENIC, INC. | FREE CHOICE | 10/11/1996 |
| K151470 | FIRST QUALITY HYGIENIC, INC. | 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 | 11/02/2015 |
| K161877 | FIRST QUALITY HYGIENIC, INC. | 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 Tam | 08/05/2016 |
| K954445 | HYGIEIA HEALTHCARE LTD. | NON APPLICATOR TAMPON, UNTREATED | 02/12/1996 |
| K182142 | Jiangsu YOAI Technology co., Ltd. | FEMME Applicator Tampon | 08/28/2019 |
| K103311 | KIMBERLY CLARK CORPORATION | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS | 12/10/2010 |
| K091749 | KIMBERLY-CLARK CORP. | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS | 12/23/2009 |
| K141294 | KIMBERLY-CLARK CORP. | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | 08/25/2014 |
| K112635 | KIMBERLY-CLARK CORP. | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | 10/07/2011 |
| K113036 | KIMBERLY-CLARK CORPORATION | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | 11/02/2011 |
| K172118 | Kimberly-Clark Corporation | U by Kotex Click Unscented Menstrual Tampons | 10/11/2017 |
| K223749 | Kimberly-Clark Corporation | U by Kotex« Click« Unscented Menstrual Tampons | 01/06/2023 |
| K090098 | MAXIM HYGIENE PRODUCTS, INC. | MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON | 01/30/2009 |
| K023789 | MCNEIL-PPC, INC. | O.B. TAMPONS | 12/06/2002 |
| K130609 | NATURALENA BRANDS, INC. | VEEDA 100% COTTON MENSTRUAL TAMPON | 03/21/2013 |
| K122603 | ONTEX BVBA | ONTEX AND OTHER PROPRIETARY NAMES | 12/19/2012 |
| K162746 | ONTEX BVBA | Ontex and other proprietary names | 03/03/2017 |
| K132595 | ONTEX BVBA | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS | 04/23/2014 |
| K142786 | ONTEX BVBA | Ontex Unscented Tampons with Colored Plastic Applicators | 06/23/2015 |
| K191666 | ONTEX BVBA | Unscented W long plastic and cardboard applicator tampons | 12/20/2019 |
| K090819 | ONTEX INTERNATIONAL NV | ONTEX TAMPON (UNSCENTED) | 12/23/2009 |
| K983478 | ORGANIC ESSENTIALS | ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON | 11/09/1998 |
| K981953 | PARAGON TRADE BRANDS, INC. | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | 08/18/1998 |
| K983381 | PARAGON TRADE BRANDS, INC. | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | 10/19/1998 |
| K974629 | PERSONAL PRODUCTS CO. | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | 02/10/1998 |
| K970954 | PERSONAL PRODUCTS CO. | O.B. APPLICATOR TAMPONS | 06/10/1997 |
| K991118 | PERSONAL PRODUCTS CO. | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | 06/29/1999 |
| K990536 | PERSONAL PRODUCTS CO. | O.B. TAMPON | 08/31/1999 |
| K180167 | Playtex Manufacturing, Inc. | Playtex Stella Tampons | 05/30/2018 |
| K032636 | PLAYTEX PRODUCTS, INC. | PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) | 11/14/2003 |
| K971174 | PLAYTEX, INC. | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | 05/21/1997 |
| K980478 | PLAYTEX, INC. | PLAYTEX TAMPONS #03498 | 04/03/1998 |
| K993794 | PLAYTIME PRODUCTS, INC. | PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS | 02/07/2000 |
| K981760 | PLAYTIME PRODUCTS, INC. | PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 | 07/22/1998 |
| K062638 | PROCTER & GAMBLE CO. | TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS | 11/22/2006 |
| K051290 | PROCTER & GAMBLE CO. | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) | 12/27/2005 |
| K091281 | PROCTER & GAMBLE CO. | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA | 06/01/2010 |
| K002096 | PROCTER & GAMBLE CO. | TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR | 09/08/2000 |
| K061486 | PROCTER & GAMBLE CO. | TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) | 08/01/2006 |
| K040999 | PROCTER & GAMBLE CO. | TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) | 07/09/2004 |
| K131543 | PROCTER & GAMBLE CO. | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | 06/20/2013 |
| K190218 | Qingdao Youjia Hygiene Technology Co., Ltd | Unscented Menstrual Tampon | 05/09/2019 |
| K192557 | Qingdao Youjia Hygiene Technology Co., Ltd | Youjia Unscented Tampon with Plastic Applicators | 02/13/2020 |
| K182814 | Rael, Inc. | Rael Tampon | 07/15/2019 |
| K970232 | REGU-TECH ASSOC., INC. | FEMTEX 100% COTTON DENTLE TOUCH TAMPONS | 03/21/1997 |
| K971228 | REGU-TECH ASSOC., INC. | FEMTEX 100% COTTON TAMPONS | 04/09/1997 |
| K020535 | ROSTAM LTD. | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | 05/09/2002 |
| K030474 | ROSTAM LTD. | PH BUFFERING PLASTIC APPLICATOR TAMPON | 05/28/2004 |
| K965064 | ROSTAM LTD. | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON | 02/20/1997 |
| K090071 | ROSTAM LTD. | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS | 05/28/2009 |
| K102445 | ROSTAM LTD. | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS | 11/10/2010 |
| K062001 | ROSTAM LTD. | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | 12/07/2006 |
| K001641 | ROSTAM LTD. | TAMPONS | 08/03/2000 |
| K961926 | SANPOINT AB | SANPOINT MENSTRUAL TAMPON | 07/15/1996 |
| K222046 | Suzhou Borage Medical Technology Co., Ltd. | Unscented Menstrual Tampon | 09/30/2022 |
| K182817 | Taebong Co., Ltd | CottonDay Tampon | 07/22/2019 |
| K962712 | TALBOT S. LINDSTROM | YSANPOINT) (MENSTRUAL) DIGITAL TAMPON | 09/10/1996 |
| K960341 | TAMBRANDS, INC. | TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS | 04/17/1996 |
| K962476 | TAMBRANDS, INC. | UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR | 08/13/1996 |
| K230419 | Tampro Inc | Sequel Tampon with Plastic Applicator | 08/03/2023 |
| K110669 | THE PROCTER & GAMBLE CO. | TAMPAX C PLASTIC TAMPONS, UNSCENTED | 06/02/2011 |
| K133244 | THE PROCTER & GAMBLE COMPANY | TAMPAX M PLASTIC TAMPONS, UNSCENTED | 01/09/2014 |
| K113699 | THE PROCTER & GAMBLE COMPANY | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | 01/12/2012 |
| K180850 | Thinx, Inc. | re.t.a Reuseable Tampon Applicator | 08/20/2018 |
| K080775 | TOSAMA D.D. | MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS | 09/10/2008 |
| K092054 | TOSAMA D.D. | MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON | 07/29/2009 |
| K120481 | TOSAMA D.O.O. | LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, | 07/13/2012 |
| K150897 | TOSAMA D.O.O. | Tosama 100% Cotton Menstrual Tampon | 04/20/2015 |
| K151170 | TOSAMA D.O.O. | Tosama 100% Organic Cotton Menstrual Tampon | 07/02/2015 |
| K172504 | TOSAMA, d.o.o. | Tosama Biobased Applicator Tube Menstrual Tampon | 02/09/2018 |
| K231341 | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | Organic cotton tampon, Viscose tampon | 08/14/2023 |
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