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
Nov 25, 2013K132597BLACK COLOURED CONDOM
Karex Industries Sdn. Bhd., MY
HIS
Oct 24, 2013K131887TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
Church & Dwight Co., Inc.
HIS
Sep 27, 2013K122219THEYFIT MALE CONDOM
Theyfit
HIS
Feb 14, 2013K121241MALE LATEX CONDOM
Nulatex Sdn. Bhd., MY
HIS
Nov 2, 2012K120555LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
Medical-Latex (Dua) Sdn. Bhd, MY
HIS
Jul 3, 2012K113056ORANGE COLORED CONDOMS ORANGE SCENT
Karex Industries Sdn. Bhd., MY
HIS
Jun 19, 2012K120286TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
Church & Dwight Co., Inc.
HIS
May 16, 2012K120287TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
Church & Dwight Co., Inc.
HIS
May 11, 2012K120249TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
Church & Dwight Virginia Co., Inc.
HIS
May 8, 2012K120394LIFESTYLES ZERO LUBRICATED LATEX CONDOM
Ansell Heathcare Products, LLC
HIS
Mar 6, 2012K113686KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
Mayer Laboratories, Inc.
HIS
Dec 7, 2011K113061LARGE/EXTRA LAGRE CONDOM
Karex Industries Sdn. Bhd., MY
HIS
Jun 3, 2011K111093BILLY BOY MALE LATEX CONDOM
Mapa GmbH, DE
HIS
Feb 24, 2011K103119BILLY BOY MALE LATEX CONDOM
Sheila Pickering PHD
HIS
May 12, 2010K092586MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
Innolatex (Thailand) Limited, TH
HIS
Oct 16, 2009K081265THAI NIPPON MALE LATEX CONDOM
Thai Nippon Rubber Industry Co., Ltd.
HIS
Sep 16, 2009K083817M. DIOR BRAND
Suzhou Colour-Way Enterprise Development Co., Ltd., CN
HIS
May 1, 2009K082529ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
Alatech Healthcare, LLC
HIS
Mar 31, 2009K090259OKAMOTO ULTRA THIN
Okamoto USA, Inc.
HIS
Feb 6, 2009K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
Karex Industries Sdn. Bhd., MY
HIS
Oct 24, 2008K081413TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
Dailian Latex Company, Ltd., CN
HIS
Aug 7, 2008K080833LOVE GUARD MALE LATEX CONDOM
Tianjin Human-Care Latex Corporation
HIS
Jan 14, 2008K070511RICHTER MALE LATEX CONDOM
Richter Rubber Technology Sbn Bhd
HIS
Nov 15, 2007K072747UNIDUS MAGNUM MALE LATEX CONDOM
Unidus Corp.
HIS
Nov 9, 2007K073016TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
Church & Dwight Co., Inc.
HIS
Oct 26, 2007K071313TROJAN-ENZ BRAND
Church & Dwight Co., Inc.
HIS
Sep 21, 2007K070937MULTIPLE BRAND MALE LATEX CONDOM
Nulatex Sdn. Bhd., MY
HIS
Sep 12, 2007K071272TROJAN THINTENSITY BRAND MALE LATEX CONDOM
Church & Dwight Co., Inc.
HIS
May 8, 2007K070830MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
Karex Industries Sdn. Bhd., MY
HIS
Mar 26, 2007K063401BANANA RIBBED
Medtech Products , Ltd.
HIS
Oct 5, 2006K062730NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
Biogreen Medical Sdn. Bhd., MY
HIS
Sep 12, 2006K052206ZEUS MALE CONDOM APPLICATOR
Condax, LLC
HIS
Apr 14, 2006K051842GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
Cupid Condom, Ltd., IN
HIS
Apr 7, 2006K060797NAKED
Veraxis Int'L, Inc.
HIS
Apr 4, 2006K050913DICK'S FORMALWEAR MALE LATEX CONDOM
Dick'S Formalwear, Inc.
HIS
Feb 21, 2006K053367MALE NATURAL RUBBER LATEX CONDOM
Innolatex Sdn. Bhd, MY
HIS
Feb 3, 2006K051288VIELLE LUBRICANT
Cst Medical Limited
HIS
Jan 27, 2006K052959DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
Ssl Americas
HIS
Aug 19, 2005K051273DIVAS DUAL PLEASURE MALE LATEX CONDOM
Eagle Twe, Inc.
HIS
Apr 8, 2005K050244MALE NATURAL RUBBER LATEX CONDOM
Nrs Global Partners
HIS
Apr 5, 2005K042470DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
Ssl Americas, Inc.
HIS
Mar 1, 2005K050360TULIP CONDOM
Shanghai Latex Factory, CN
HIS
Feb 17, 2005K042957DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
Ssl Americas
HIS
Jan 13, 2005K041717POWERSTICK MALE LATEX CONDOMS
A.P.Deauville, LLC
HIS
Jan 13, 2005K041667SAN-MAR LABS LUBRICATING JELLY
San-Mar Laboratories, Inc.
HIS
Nov 30, 2004K041432ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
Biofilm, Inc.
HIS
Sep 24, 2004K041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
Innolatex Sdn. Bhd
HIS
Apr 27, 2004K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
Ssl Americas
HIS
Apr 20, 2004K040085PERSONAL WARMING LUBRICANT
Qualis, Inc.
HIS
Mar 29, 2004K032227DUREX FLAVORED LATEX CONDOM
Ssl Americas, Inc.
HIS

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