Medical Device Manufacturer · US , Mchenry , IL

Playtex, Inc.

20 submissions · 18 cleared · Since 1981
20
Total
18
Cleared
0
Denied

Playtex, Inc. — FDA 510(k) Submissions

Playtex, Inc. has submitted 20 FDA 510(k) premarket notifications since 1981, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tampon, Menstrual, Scented, Scented-deodorized, Tampon, Menstrual, Unscented . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K120245 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jun 2012 146d
PLAYTEX TAMPONS #03498
K980478 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Apr 1998 56d
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
K971174 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
May 1997 51d
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944064 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Feb 1995 174d
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
K941044 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jul 1994 142d
PLAYTEX TAMPONS MODEL 13794
K942418 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Jul 1994 49d
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
K881057 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 1988 11d
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
K874509 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jan 1988 66d
PLAYTEX BABY POWDER DEODORANT TAMPONS
K843551 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Dec 1984 84d
PLAYTEX SLENDER REGULAR TAMPONS
K841154 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 1984
DEODORANT SLENDER REG. TAMPONS
K841155 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 1984
PLAYTEX TAMPONS
K830966 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Apr 1983 11d
IMPROVED PLAYTEX TAMPON
K812870 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Oct 1981 15d
IMPROVED PLAYTEX TAMPON
K812534 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Sep 1981 18d
PLAYTEX DIGITAL TAMPON
K811385 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Aug 1981 81d
PLAYTEX COMBINATION FIBER MODIFIED TAMP
K811387 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Aug 1981 81d
PLAYTEX COTTON DIGITAL TAMPON
K811388 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Aug 1981 81d
PLAYTEX COTTON TAMPONS
K811389 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Aug 1981 81d
PLAYTEX MODIFIED FIBER TAMPONS
K811660 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jul 1981 34d
PLAYTEX PROCESS MACHINERY CHANGE
K811386 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jul 1981 53d
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