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
Jan 16, 2004K032124DUREX PLAY LUBRICANT
Ssl Americas, Inc.
HIS
Dec 23, 2003K033541LONG LOVE CONDOM
Unidus Corp.
HIS
Dec 19, 2003K033076LIFESTYLES LIQUID PERSONAL LUBRICANT
Ansell Healthcare, Inc.
HIS
Dec 16, 2003K032909THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
Thai Nippon Rubber Industry Co., Ltd.
HIS
Nov 14, 2003K031007KWIKEZE MALE CONDOM APPLICATOR
Condax, LLC
HIS
Oct 31, 2003K031369MERCATOR HEALTHCARE MALE LATEX CONDOM
Mercator Healthcare , Ltd.
HIS
Jun 23, 2003K023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
Pleasure Latex Products Sdn. Bhd., MY
HIS
Apr 17, 2003K030176LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
Suretex, Ltd.
HIS
Apr 8, 2003K022614INVIGRA
Indus Medicare , Ltd., IN
HIS
Mar 25, 2003K024324LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
Global Protection Corp.
HIS
Jan 22, 2003K023128NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Secure Scientific Sdn Bhd, MY
HIS
Dec 16, 2002K023405TROJAN MINT TINGLE BRAND LATEX CONDOMS
Armkel, LLC
HIS
Dec 13, 2002K023176UNDUS MALE LATEX CONDOM (WITH FLAVORING)
Unidus Corp.
HIS
Dec 13, 2002K023175UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
Unidus Corp.
HIS
Dec 13, 2002K023129UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
Unidus Corp.
HIS
Dec 12, 2002K023059UNIDUS MALE LATEX CONDOM
Unidus Corp.
HIS
Oct 25, 2002K021186CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
Condomi Erfert Prodoktionsgesellschaft Mbh
HIS
Oct 25, 2002K021125SENSUA!
Aac Consulting Group, Inc.
HIS
Sep 5, 2002K021875MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
Pleasure Latex Products Sdn. Bhd., MY
HIS
May 15, 2002K020633NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
Ls Rubber Sdn Bhd
HIS
Apr 26, 2002K020272MALE LATEX CONDOM WITH RIBBED SURFACE
Pleasure Latex Products Sdn. Bhd., MY
HIS
Mar 29, 2002K020659DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Ssl Americas, Inc.
HIS
Mar 25, 2002K011378JOE LUB HELMET CONDOM
Marketing Sales Concepts, Inc. (Msci)
HIS
Mar 25, 2002K011363JOE LUBE CONDOM
Marketing Sales Concepts, Inc. (Msci)
HIS
Mar 4, 2002K020223INVIGRA
Indus Medicare , Ltd., IN
HIS
Jan 24, 2002K013773SAFE
Ssn Medical Products Sdn. Bhd., MY
HIS
Dec 13, 2001K013086WET LIGHT PERSONAL MOISTURIZER
Trigg Laboratories, Inc.
HIS
Nov 9, 2001K01296456MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
Innolatex Sdn. Bhd, MY
HIS
Nov 9, 2001K012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
Innolatex Sdn. Bhd, MY
HIS
Nov 9, 2001K012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
Innolatex Sdn. Bhd, MY
HIS
Nov 9, 2001K012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
Innolatex Sdn. Bhd, MY
HIS
Sep 21, 2001K012653MALE LATEX CONDOM
Qingdao Shuang Die Latex Production Co.,Ltd
HIS
Jul 20, 2001K011253FLAVORED MALE LATEX CONDOM
Thai Nippon Rubber Industry Co., Ltd.
HIS
Jun 15, 2001K010919MALE NATURAL RUBBER LATEX CONDOM
Innolatex Sdn. Bhd, MY
HIS
May 24, 2001K011480VIVA
Richter Rubber Technology Sdn. Bhd.
HIS
Apr 27, 2001K010371LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
Suretex, Ltd.
HIS
Mar 30, 2001K010028SHEER THIN AROMAS RED LATEX CONDOM
Eagle Twe, Inc.
HIS
Mar 29, 2001K004051SHEER THIN AROMAS YELLOW LATEX CONDOM
Eagle Twe, Inc.
HIS
Mar 27, 2001K004036SHEER THIN AROMAS GREEN LATEX CONDOM
Eagle Twe, Inc.
HIS
Mar 27, 2001K004016SHEER THIN AROMAS BLUE LATEX CONDOM
Eagle Twe, Inc.
HIS
Dec 19, 2000K002393NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Innolatex Sdn. Bhd, MY
HIS
Nov 16, 2000K002571MULITPLE MALE LATX CONDOM
Pleasure Latex Products Sdn. Bhd., MY
HIS
Sep 7, 2000K002060NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
Dongkuk Techco Rubber Industries, MY
HIS
Aug 18, 2000K993409REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
Remed Pharma
HIS
Aug 18, 2000K993403REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
Remed Pharma
HIS
Aug 18, 2000K993389REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
Remed Pharma
HIS
Aug 14, 2000K994118OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
Guilin Latex Factory
HIS
Jul 31, 2000K001883LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
Ansell Healthcare, Inc.
HIS
May 19, 2000K001221MALE LATEX COMDOM WITH DOTTED SURFACE
Pleasure Latex Products Sdn. Bhd., MY
HIS
May 9, 2000K001212TROJAN EXTRA LARGE LATEX CONDOM
Armkel, LLC
HIS

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