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

Decided510(k)Device and applicantCode
Dec 11, 1987K872861LOVIEL CONDOM
Lloviel Marketing Corp.
HIS
Dec 8, 1987K874718STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
Schmid Laboratories, Inc.
HIS
Dec 8, 1987K872799KIMONO (CONDOMS)
Mayer Laboratories
HIS
Dec 8, 1987K871451BESTCON/SPERMICIDE
Europharmaceutical Corp.
HIS
Nov 20, 1987K874464SPERMICIDAL CONDOM
Royal American Industries, Inc.
HIS
Nov 20, 1987K872504LUBRICATED CONDOM
Royal American Industries, Inc.
HIS
Nov 5, 1987K872812SKINLESS-SKIN, PINK TINT (CONDOM)
Okamoto USA, Inc.
HIS
Nov 5, 1987K872664SKINLESS SKIN-HARMONY CONDOMS
Okamoto USA, Inc.
HIS
Nov 4, 1987K872619PREVENTETTE (CONDOM)
Reb Enterprises, Inc.
HIS
Nov 2, 1987K872005MAXIMUM, LATEX PROPHYLACTIC BRAND
Safe Product Supplies
HIS
Oct 20, 1987K872736PROPHYLACTIC (CONDOM)
Circle Rubber Corp.
HIS
Oct 20, 1987K871948ANGEL LATEX PROPHYLACTICS (CONDOMS)
Angel Intl. Trading Co., Inc.
HIS
Oct 20, 1987K871036CONDOM TAKASO RUBBER PRODUCTS SDN/BDH
Takaso Rubber C/O Interstate Supplier, Inc.
HIS
Aug 5, 1987K871470BESTCON/LUBRICATED CONDOMS
Europharmaceutical Corp.
HIS
Jul 21, 1987K871020KANGLE CONDOM
Lindley Company, Inc.
HIS
Jun 11, 1987K871304LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
Ansell, Inc.
HIS
Jun 8, 1987K871300VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA
Professional Pharmacy West, Inc.
HIS
May 20, 1987K865106PROPHYLACTIC (CONDOM) MR. JOHNNY
Medelec Intl. Corp.
HIS
Mar 4, 1987K862401PERSONAL/DERBY CONDOMS
Razi Corp.
HIS
Feb 2, 1987K864400EXTRA STRONG CONDOM
Ansell, Inc.
HIS
Dec 30, 1986K864570PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
Dongkuk Techco Rubber Industries
HIS
Dec 22, 1986K864482CHOICE
Select Sources, Inc.
HIS
Dec 3, 1986K864473SEMINAL FLUID COLLECTION KIT(TM)
Apex Technologies, Inc.
HIS
Dec 3, 1986K863190CHOICE CONDOM
Select Sources, Inc.
HIS
Sep 26, 1986K863707LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40
Manexim Multicorp, Ltd., CA
HIS
Sep 26, 1986K863706LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
Manexim Multicorp, Ltd., CA
HIS
Sep 26, 1986K860680PROTEX, TAHITI CONDOM
U. C. Import & Co.
HIS
Aug 19, 1986K860909WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
U. C. Import & Co.
HIS
Apr 11, 1986K854622PROPHYLACTIC (CONDOM)
Medelec Intl. Corp.
HIS
Jan 16, 1986K854247JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS
M/S Seohung Industrial Co., Ltd.
HIS
Oct 31, 1985K852620SAFE.N.SURE
Ashai Co. , Ltd., AU
HIS
May 23, 1985K851292LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20
Manexim Multicorp, Ltd., CA
HIS
May 22, 1985K851291LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30
Manexim Multicorp, Ltd., CA
HIS
May 22, 1985K851290LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10
Manexim Multicorp, Ltd., CA
HIS
Nov 29, 1984K841600CASABLANCA
Arcon Corp.
HIS
Sep 21, 1984K842502WRINKLE CHAPEAU BLACKY
Circle Rubber Corp.
HIS
Aug 22, 1984K833365ULTRA SHAPE CONDOMS
Barnetts, Inc.
HIS
Jul 31, 1984K842185PROTEX CONTRACEPT PLUS W/SPERM-LUB
National Sanitary Laboratories, Inc.
HIS
Feb 4, 1984K834591STOPEX-CONDOMS-
Tropex Worldwide, Inc.
HIS
Dec 16, 1983K833765TROJAN PLUS II
Youngs Rubber Corp.
HIS
Sep 12, 1983K831816PROTEX CONTRACEPT PLUS W/SPERM-LUB
National Sanitary Laboratories, Inc.
HIS
Mar 31, 1983K830691PRIME
Ansell, Inc.
HIS
Feb 24, 1983K823937SEMINAL COLLECTION DEVICE
Health Development Corp.
HIS
Nov 3, 1982K822088MALE CONDOM
Schmid Laboratories, Inc.
HIS
Sep 30, 1982K822792NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
Ansell, Inc.
HIS
May 28, 1982K820564WORLD'S BEST (CONTRACEPTIVE)
Rosen Kilde Stenhoj
HIS
Mar 5, 1982K813172CONDOM-MULTIPAL STYLES
Circle Rubber Corp.
HIS
Mar 20, 1980K800518UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,
Kopharm, Inc.
HIS
Jan 16, 1980K792634CONCEPTROL/THIN PROPHYLACTICS
Ortho Pharmaceutical Corp.
HIS
Oct 4, 1979K790433NATURDOM
Juan C. Lucena
HIS

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