ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HIS · Class 2

Condom

Regulation 884.5300

3510(k)s in 12 months (402 all time)
1recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in HIS

Company510(k)sRecalls
Carter Products150
Mayer Laboratories140
Okamoto USA, Inc.140
Ansell, Inc.120
Church & Dwight Co., Inc.120
Remed Pharma90
Schmid Laboratories, Inc.90
Innolatex Sdn. Bhd80
Pleasure Latex Products Sdn. Bhd.80
Suretex Limited80
Decided510(k)Device and applicantCode
Aug 25, 1997K972428EXTRAWEAR, GENTLEMEN'S CHOICE
Custom Services Intl., Inc.
HIS
Aug 20, 1997K972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
Custom Services Intl., Inc.
HIS
Jun 2, 1997K970792INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE
Titan Condoms
HIS
Jun 2, 1997K970767CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
Custom Services Intl., Inc.
HIS
Mar 21, 1997K970633TUSTEX FLAVORED CONDOMS
Line One Laboratories
HIS
Feb 14, 1997K964599TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
Line One Laboratories
HIS
Feb 14, 1997K964598TRUSTEX COLA FLAVORD CONDOM
Line One Laboratories
HIS
Feb 13, 1997K964591TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
Line One Laboratories
HIS
Feb 11, 1997K955183SAFE KNIGHTS
L & N Corp.
HIS
Jan 22, 1997K963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
Custom Services Intl., Inc.
HIS
Jan 22, 1997K963319OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
Custom Services Intl., Inc.
HIS
Dec 12, 1996K963679LOVING SMARTER - SAFER SEX
Loving Smarter, Inc.
HIS
Oct 10, 1996K960710CONDOM
Polar Latex , Ltd.
HIS
Jul 15, 1996K946103TRUSTEX FLAVOR CONDON IN COLORS
Line One Laboratories & Trading Co.
HIS
Jun 21, 1996K955648K-Y PERSONAL LUBRICANT
Ortho Pharmaceutical Corp.
HIS
Feb 21, 1996K945145RIA LATEX CONDOM, NONOXYNOL-9
Mbf Personal Care Sdn. Bhd., MY
HIS
Feb 13, 1996K943880RIA LATEX CONDOM
Mbf Personal Care Sdn. Bhd., MY
HIS
Jan 26, 1996K953583LUBRICATED CONDOM
Tactyl Technologies, Inc.
HIS
Jan 24, 1996K946207CONQUEROR, RUMBA AND TEMPTATION
Frontline Latex Products Pvt. , Ltd.
HIS
Jan 5, 1996K954791SEMINAL FLUID COLLECTION KIT II
Apex Medical Technologies, Inc.
HIS
Dec 19, 1995K945930RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
Line One Laboratories & Trading Co.
HIS
Dec 19, 1995K940047SPERMICIDALLY LUBRICATED CONDOM
Ansell, Inc.
HIS
Dec 6, 1995K944786RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)
Line One Laboratories & Trading Co.
HIS
Dec 6, 1995K941258LATEX CONDOM
Suretex, Ltd., TH
HIS
Nov 22, 1995K952465PROBE PERSONAL LUBRICANT - SILKY LIGHT
Davryan Laboratories, Inc.
HIS
Nov 22, 1995K952464PROBE PERSONAL LUBRICANT - CLASSIC
Davryan Laboratories, Inc.
HIS
Nov 8, 1995K946374KIMONO MICROTHIN
Mayer Laboratories
HIS
Sep 22, 1995K946376MAXX
Mayer Laboratories
HIS
Sep 22, 1995K943064KIMONO (CONDOMS)
Mayer Laboratories
HIS
Sep 7, 1995K945246PREVENTOR AND PROTECTOR LATEX CONDOMS
American Pharmaceutical Co., Inc.
HIS
Aug 9, 1995K952393OKAMOTO CONDOM
Okamoto USA, Inc.
HIS
Jun 22, 1995K943933SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
Aladan Corp.
HIS
Jun 16, 1995K932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
Sime Health, Ltd.
HIS
May 18, 1995K942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
Suretex, Ltd., TH
HIS
Apr 14, 1995K943883SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
Aladan Corp.
HIS
Jan 30, 1995K940046NON-LUBRICATED CONDOM
Ansell, Inc.
HIS
Jan 30, 1995K940045CONDOM
Ansell, Inc.
HIS
Jan 3, 1995K941831LUBRICATING JELLY
Barre-National, Inc.
HIS
Dec 27, 1994K911431TACTYLON(TM) CONDOM
Tactyl Technologies, Inc.
HIS
Sep 14, 1994K931077LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE
J.K. Chemicals, Ltd.
HIS
Jul 28, 1994K933153PENTHOUSE CONDOMS
Kuron Health Products Corp.
HIS
Jul 7, 1994K932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
Sime Health, Ltd.
HIS
Jul 7, 1994K932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
Sime Health, Ltd.
HIS
Jul 7, 1994K932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
Sime Health, Ltd.
HIS
Feb 22, 1994K920514SPIRAL
Thornton Associates, Inc.
HIS
Sep 1, 1993K922889CONDOOM SHELF LIFE -- MODIFICATIONS
Safetex Corp.
HIS
Jul 21, 1992K912405LATEX PROPHYLACTIC (CONDOM)
Hevealactics Intl. Sdn Bhd
HIS
Jun 1, 1992K913813JIFFI CONDOM (RUBBER) CONTRACEPTIVE
Sime Health, Ltd.
HIS
Feb 3, 1992K912901TROJAN (TM-TBD) CONDOM
Carter Products
HIS
Dec 18, 1991K910470CONDOMS, MOODS/SHARE & RAKSHAK
Hindustan Latex , Ltd.
HIS

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