Okamoto USA, Inc. - FDA 510(k) Cleared Devices

Cleared May 04, 2026

Male Latex Condom HA

K252622 · HIS

Obstetrics & Gynecology · 258d

Cleared Feb 18, 2025

0.04 ZERO ZERO FOUR Male Latex Condom

K243584 · HIS

Obstetrics & Gynecology · 90d

Cleared Feb 25, 2022

Okamoto 002 Lubricated Polyurethane Male Condom

K203541 · MOL

Obstetrics & Gynecology · 449d

Cleared Jul 24, 2020

Extremely Thin 003, ZERO ZERO THREE

K192669 · HIS

Obstetrics & Gynecology · 303d

Cleared Jul 23, 2014

OKAMOTO STUDDED CONDOM

K141256 · HIS

Obstetrics & Gynecology · 70d

Cleared Jul 01, 2014

MEGA BIG BOY CONDOM

K140379 · HIS

Obstetrics & Gynecology · 137d

Cleared Mar 31, 2009

OKAMOTO ULTRA THIN

K090259 · HIS

Obstetrics & Gynecology · 57d

Cleared Aug 09, 1995

OKAMOTO CONDOM

K952393 · HIS

Obstetrics & Gynecology · 79d

Cleared Aug 13, 1990

EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT

K902804 · HIS

Obstetrics & Gynecology · 47d

Cleared Jan 10, 1990

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM

K896339 · HIS

Obstetrics & Gynecology · 68d

Cleared Mar 10, 1989

EXTRA STRENGTH SKIN LESS SKIN CONDOM

K884402 · HIS

Obstetrics & Gynecology · 142d

Cleared Jan 12, 1989

SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT

K884401 · HIS

Obstetrics & Gynecology · 85d