Medical Device Manufacturer · US , Paramus , NJ

Playtex Products, Inc.

17 submissions · 17 cleared · Since 1995
17
Total
17
Cleared
0
Denied

Playtex Products, Inc. — FDA 510(k) Submissions

Playtex Products, Inc. has submitted 17 FDA 510(k) premarket notifications since 1995, of which 17 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, Pump, Breast, Powered, Speculum, Vaginal, Nonmetal . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
K073662 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jan 2008 22d
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
K072376 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Dec 2007 110d
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
K070745 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Apr 2007 25d
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Aug 2006 124d
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K060981 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
May 2006 29d
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K032636 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Nov 2003 79d
PLAYTEX BREAST PUMP
K022594 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Nov 2002 88d
MODIFICATION TO PLAYTEX TAMPONS #24002
K022882 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Sep 2002 17d
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 2002 50d
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 2002 49d
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Mar 2002 49d
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K982383 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Aug 1998 42d
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS
K971979 · HIB Speculum, Vaginal, Nonmetal · Obstetrics & Gynecology
Sep 1997 120d
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
K971547 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jun 1997 52d
PLAYTEX SLIMFIT TAMPONS
K961870 · HIL Tampon, Menstrual,... · Obstetrics & Gynecology
Jun 1996 40d
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944154 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Feb 1995 174d
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944155 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology
Feb 1995 174d
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