Okamoto USA, Inc. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) cleared devices by Okamoto USA, Inc. Obstetrics & Gynecology ✕
14 devices
Cleared
Feb 18, 2025
0.04 ZERO ZERO FOUR Male Latex Condom
Obstetrics & Gynecology
90d
Cleared
Feb 25, 2022
Okamoto 002 Lubricated Polyurethane Male Condom
Obstetrics & Gynecology
449d
Cleared
Jul 24, 2020
Extremely Thin 003, ZERO ZERO THREE
Obstetrics & Gynecology
303d
Cleared
Jul 23, 2014
OKAMOTO STUDDED CONDOM
Obstetrics & Gynecology
70d
Cleared
Jul 01, 2014
MEGA BIG BOY CONDOM
Obstetrics & Gynecology
137d
Cleared
Mar 31, 2009
OKAMOTO ULTRA THIN
Obstetrics & Gynecology
57d
Cleared
Aug 09, 1995
OKAMOTO CONDOM
Obstetrics & Gynecology
79d
Cleared
Aug 13, 1990
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
Obstetrics & Gynecology
47d
Cleared
Jan 10, 1990
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
Obstetrics & Gynecology
68d
Cleared
Mar 10, 1989
EXTRA STRENGTH SKIN LESS SKIN CONDOM
Obstetrics & Gynecology
142d
Cleared
Jan 12, 1989
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
Obstetrics & Gynecology
85d
Cleared
Feb 26, 1988
RUBBER CONTRACEPTIVE, LATEX CONDOMS
Obstetrics & Gynecology
74d
Cleared
Nov 05, 1987
SKINLESS SKIN-HARMONY CONDOMS
Obstetrics & Gynecology
120d
Cleared
Nov 05, 1987
SKINLESS-SKIN, PINK TINT (CONDOM)
Obstetrics & Gynecology
112d