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Okamoto USA, Inc.

15 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Male Latex Condom HA (K252622)Okamoto USA, Inc.2026-05-04
0.04 ZERO ZERO FOUR Male Latex Condom (K243584)Okamoto USA, Inc.2025-02-18
Okamoto 002 Lubricated Polyurethane Male Condom (K203541)Okamoto USA, Inc.2022-02-25
Extremely Thin 003, ZERO ZERO THREE (K192669)Okamoto USA, Inc.2020-07-24
OKAMOTO STUDDED CONDOM (K141256)Okamoto USA, Inc.2014-07-23
MEGA BIG BOY CONDOM (K140379)Okamoto USA, Inc.2014-07-01
OKAMOTO ULTRA THIN (K090259)Okamoto USA, Inc.2009-03-31
OKAMOTO CONDOM (K952393)Okamoto USA, Inc.1995-08-09
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT (K902804)Okamoto USA, Inc.1990-08-13
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM (K896339)Okamoto USA, Inc.1990-01-10
EXTRA STRENGTH SKIN LESS SKIN CONDOM (K884402)Okamoto USA, Inc.1989-03-10
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT (K884401)Okamoto USA, Inc.1989-01-12
RUBBER CONTRACEPTIVE, LATEX CONDOMS (K875111)Okamoto USA, Inc.1988-02-26
SKINLESS-SKIN, PINK TINT (CONDOM) (K872812)Okamoto USA, Inc.1987-11-05
SKINLESS SKIN-HARMONY CONDOMS (K872664)Okamoto USA, Inc.1987-11-05

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Every clearance here is in the API, with alerts when new ones post.