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 |