Okamoto USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K2435840.04 ZERO ZERO FOUR Male Latex CondomFebruary 18, 2025
K203541Okamoto 002 Lubricated Polyurethane Male CondomFebruary 25, 2022
K192669Extremely Thin 003, ZERO ZERO THREEJuly 24, 2020
K141256OKAMOTO STUDDED CONDOMJuly 23, 2014
K140379MEGA BIG BOY CONDOMJuly 1, 2014
K090259OKAMOTO ULTRA THINMarch 31, 2009
K952393OKAMOTO CONDOMAugust 9, 1995
K902804EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANTAugust 13, 1990
K896339MODIFIED LABELING ON OKAMOTO HARMONY CONDOMJanuary 10, 1990
K884402EXTRA STRENGTH SKIN LESS SKIN CONDOMMarch 10, 1989
K884401SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANTJanuary 12, 1989
K875111RUBBER CONTRACEPTIVE, LATEX CONDOMSFebruary 26, 1988
K872812SKINLESS-SKIN, PINK TINT (CONDOM)November 5, 1987
K872664SKINLESS SKIN-HARMONY CONDOMSNovember 5, 1987