Okamoto USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Okamoto USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Male Latex Condom HA, 0.04 ZERO ZERO FOUR Male Latex Condom, Okamoto 002 Lubricated Polyurethane Male Condom
15
Total
15
Cleared
0
Denied
Okamoto USA, Inc. has 15 FDA 510(k) cleared obstetrics & gynecology devices. Based in Stratford, US.
Latest FDA clearance: May 2026. Active since 1987.
Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hyman, Phelps & McNamara, P.C. as regulatory consultant.
FDA 510(k) Regulatory Record - Okamoto USA, Inc.
15 devices
Cleared
May 04, 2026
Male Latex Condom HA
Obstetrics & Gynecology
258d
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