Atlas FDA

HIL

84 FDA 510(k) clearances · Product code

49 daysmedian time to decision
144 days90th percentile
84clearances measured

FDA profile

Official device name
Tampon, Menstrual, Scented, Scented-Deodorized
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5460
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
FDA definition
A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Adverse events (MAUDE)
2007: 8 · 2008: 8 · 2009: 13 · 2010: 11 · 2013: 9 · 2020: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ONTEX AND OTHERS PROPRIETARY NAMES (K132208)Ontex Bvba2014-04-10
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (K132819)Playtex Manufacturing, Inc.2013-10-09
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (K120245)Playtex, Inc.2012-06-21
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (K111684)Playtex Manufacturing, Inc.2012-02-03
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (K081555)Procter & Gamble Co.2008-06-27
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (K073662)Playtex Products, Inc.2008-01-17
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (K072376)Playtex Products, Inc.2007-12-12
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS (K070745)Playtex Products, Inc.2007-04-13
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (K060981)Playtex Products, Inc.2006-05-09
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (K051446)First Quality Hygienic, Inc.2005-07-14
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (K050067)First Quality Hygienic, Inc.2005-02-01
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (K042773)Rostam , Ltd.2004-11-23
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS (K040312)Procter & Gamble Co.2004-05-03
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (K032173)First Quality Hygienic, Inc.2003-09-03
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS (K032080)Rostam , Ltd.2003-08-14
MODIFICATION TO PLAYTEX TAMPONS #24002 (K022882)Playtex Products, Inc.2002-09-16
PLAYTEX DEODORANT TAMPONS, MODEL 34802 (K020200)Playtex Products, Inc.2002-03-13
PLAYTEX DEODORANT TAMPONS, MODEL 34702 (K020202)Playtex Products, Inc.2002-03-12
PLAYTEX DEODORANT TAMPONS, MODEL 34902 (K020201)Playtex Products, Inc.2002-03-12
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS (K011996)Procter & Gamble Co.2001-09-19
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS (K011171)Procter & Gamble Co.2001-07-02
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS (K982383)Playtex Products, Inc.1998-08-19
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS (K971547)Playtex Products, Inc.1997-06-19
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS (K964269)Playtime Products, Inc.1996-11-29
PLAYTEX SLIMFIT TAMPONS (K961870)Playtex Products, Inc.1996-06-19
PLAYTEX TAMPONS #10296 (K961456)Playtime Products, Inc.1996-06-18
O.B. APPLICATOR TAMPONS (K953638)Personal Products Co.1995-10-20
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS (K952344)Tambrands, Inc.1995-07-28
ULTIMATES SILK GLIDE TAMPONS (K950928)Playtime Products, Inc.1995-03-22
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 (K941044)Playtex, Inc.1994-07-27
PLATEX TAMPONS MODEL NUMBER 07094 (K941196)Playtex Family Products, Inc.1994-04-19
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED (K940821)Playtex Family Products, Inc.1994-03-25
PLAYTEX ULTIMATES TAMPONS (K932909)Playtex Family Products, Inc.1994-03-07
PLAYTEX ULTIMATES TAMPONS (K932907)Playtex Family Products, Inc.1994-03-07
PLAYTEX ULTIMATES TAMPONS (K934083)Playtex Family Products, Inc.1994-03-07
PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED (K936189)Playtex Family Products, Inc.1994-03-07
PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS (K935276)Playtex Family Products, Inc.1994-03-07
TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY (K922834)Playtex Family Products, Inc.1993-09-01
PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + (K924279)Playtex Family Products, Inc.1993-05-21
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS (K914438)Playtex Family Products, Inc.1992-01-02
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS (K912002)Playtex Family Products, Inc.1991-08-12
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS (K905378)Playtex Family Products, Inc.1991-02-11
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS (K897012)Playtex Family Products, Inc.1989-12-22
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (K896115)Tambrands, Inc.1989-12-13
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS (K891297)Playtex Family Products, Inc.1989-06-08
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS (K884737)Playtex Family Products, Inc.1989-01-10
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER (K881057)Playtex, Inc.1988-03-22
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS (K880024)Tambrands, Inc.1988-03-08
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON (K880022)Tambrands, Inc.1988-03-02
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON (K880023)Tambrands, Inc.1988-03-02
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (K873457)Procter & Gamble Mfg. Co.1988-01-19
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL (K874509)Playtex, Inc.1988-01-07
TAMPAX DEODORANT TAMPON, SUPER (K872261)Tambrands, Inc.1987-07-14
TAMPAX DEODORANT TAMPON, SLENDER REGULAR (K872260)Tambrands, Inc.1987-07-10
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS (K872258)Tambrands, Inc.1987-07-10
TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR (K872256)Tambrands, Inc.1987-07-10
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER (K872259)Tambrands, Inc.1987-07-10
TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR (K872257)Tambrands, Inc.1987-07-10
TAMPAX DEODORANT TAMPON, SUPER PLUS (K872255)Tambrands, Inc.1987-07-10
PLAYTEX TAMPONS AND DEODORANT TAMPONS (K871197)Intl. Playtex, Inc.1987-05-12
O.B.(TM) TAMPON (K864498)Personal Products Co.1987-01-27
PLAYTEX TAMPONS (K861738)Intl. Playtex, Inc.1986-07-22
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION) (K862353)Tambrands, Inc.1986-07-09
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA (K854258)Intl. Playtex, Inc.1985-11-21
PLAYTEX BABY POWDER DEODORANT TAMPONS (K843551)Playtex, Inc.1984-12-03
PLAYTEX SLENDER REGULAR TAMPONS (K841154)Playtex, Inc.1984-03-19
DEODORANT SLENDER REG. TAMPONS (K841155)Playtex, Inc.1984-03-19
PLAYTEX TAMPONS (K830966)Playtex, Inc.1983-04-08
ASSURE NATURAL FIT TAMPON (K812618)Personal Products Co.1981-10-02
IMPROVED PLAYTEX TAMPON (K812534)Playtex, Inc.1981-09-21
PLAYTEX COMBINATION FIBER MODIFIED TAMP (K811387)Playtex, Inc.1981-08-07
PLAYTEX COTTON TAMPONS (K811389)Playtex, Inc.1981-08-07
PLAYTEX MODIFIED FIBER TAMPONS (K811660)Playtex, Inc.1981-07-16
PLAYTEX PROCESS MACHINERY CHANGE (K811386)Playtex, Inc.1981-07-10
ASSURE NATURAL FIT TAMPON (K811214)Personal Products Co.1981-05-21
TAMPAX DEODORANT TAMPONS (K810143)Tampax, Inc.1981-03-04
RELY DEODERANT TAMPON (K800272)Procter & Gamble Mfg. Co.1980-02-26
STERILIZATION PROCESS/MATERNITY PAD (K792627)Procter & Gamble Mfg. Co.1980-01-28
ASSURE NATURAL FIT TAMPON (K781085)Personal Products Co.1978-07-17
TAMPON, HEAVY DUTY, & STICK (K780058)Kimberly-Clark Corp.1978-01-26
ASSURE DEODORANT TAMPONS (K771012)Personal Products Co.1977-06-24
RELY TAMPON (K761184)Procter & Gamble Mfg. Co.1976-12-17
TAMPON, PLAYTEX 2 VERSION A (K760425)Intl. Playtex, Inc.1976-09-13
TAMPON, PLAYTEX 2 VERSION B (K760426)Intl. Playtex, Inc.1976-08-26

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