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 14, 1991K902772PLEASURE PLUS
Medimix Products, Inc.
HIS
Jun 4, 1991K910284CONDOMS (RUBBER CONTRACEPTIVES)
Suretex, Ltd.
HIS
Jun 3, 1991K910550CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
Safetex Corp.
HIS
May 9, 1991K910788CMI TENDER TOUCH VE #303TT AND 404TT
Challenge Mfg., Inc.
HIS
Apr 3, 1991K910578MCLAUGHLIN LAPAROSCOPIC GRASPER
Marlo Surgical Technology
HIS
Mar 29, 1991K902324TP AND DESIGN, CONDOM
China National Medicines & Health Prod. I/E Corp.
HIS
Mar 29, 1991K902305TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
Armkel, LLC
HIS
Mar 6, 1991K902936POLYURETHANE CONDOM
Apex Medical Technologies, Inc.
HIS
Feb 19, 1991K905279CONDOM (RUBBER) CONTRACEPTIVE
Aladan Corp.
HIS
Feb 19, 1991K904000TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
Armkel, LLC
HIS
Feb 15, 1991K905854CONDOMS
Barnetts, Inc.
HIS
Dec 21, 1990K902907MAMBA CONDOM (RUBBER LATEX)
Rfsu, SE
HIS
Dec 19, 1990K896098GUARDIAN & JANITEX CONDOM/PROPHYLACTIC
Allied Rubber Industries Sdn. Bhd., MY
HIS
Nov 26, 1990K904375KIMONO PLUS
Mayer Laboratories
HIS
Nov 23, 1990K904453LABELLING MODIFICATION TO MAXX PLUS
Mayer Laboratories
HIS
Nov 20, 1990K904840ORION PLUS/MODIFICATION
Mayer Laboratories
HIS
Aug 13, 1990K902804EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
Okamoto USA, Inc.
HIS
Jul 24, 1990K902509SAXON RIBBED CONDOMS
Safetex Corp.
HIS
Jul 13, 1990K897140THIN CONDOM RAMSES & SHEIK
Schmid Laboratories, Inc.
HIS
Jun 29, 1990K896107RUBBER CONTRACEPTIVE
Banrub Sdn Bhd, MY
HIS
Jun 19, 1990K901202TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
Carter Products
HIS
Jun 7, 1990K900679MINT SCENTED CONDOMS
Schmid Laboratories, Inc.
HIS
Jun 6, 1990K896987RUBBER CONDOM (NON-COLORED)
Hankook Latex Gongup Co., Ltd., KR
HIS
Jun 6, 1990K896142RUBBER CONTRACEPTIVE (CONDOM)
Guangzhou No. 11 Rubber Factory
HIS
Jun 4, 1990K901416CONDOM (RUBBER) CONTRACEPTIVE
Aladan Corp.
HIS
May 16, 1990K901696LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033
Allercare/Nsl, Inc.
HIS
May 16, 1990K901669LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000
Allercare/Nsl, Inc.
HIS
May 16, 1990K901668LATEX CONDOMS - CODE NO. 402, CODE NO. 1028
Allercare/Nsl, Inc.
HIS
May 16, 1990K901667LATEX CONDOMS - CODE NO. 401, 421 & 1002
Allercare/Nsl, Inc.
HIS
May 16, 1990K897129CONDOMS (MULTIPLE BRANDS)
Sagami, Inc.
HIS
May 4, 1990K893039CONDOM (RUBBER) CONTRACEPTIVE
Chinteik Hygiene Products Co., Ltd., TH
HIS
Apr 16, 1990K901201TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED
Carter Products
HIS
Apr 16, 1990K901200TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
Carter Products
HIS
Apr 16, 1990K901199TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED
Carter Products
HIS
Apr 16, 1990K901198TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED
Carter Products
HIS
Apr 16, 1990K901197TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL
Carter Products
HIS
Apr 16, 1990K901196TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING
Carter Products
HIS
Apr 16, 1990K901195TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED
Carter Products
HIS
Apr 16, 1990K901194TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL
Carter Products
HIS
Apr 16, 1990K901193TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)
Carter Products
HIS
Apr 16, 1990K901192TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
Carter Products
HIS
Apr 16, 1990K901191TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
Carter Products
HIS
Apr 16, 1990K901190TROJANS LATEX CONDOMS (MODIFIED LABELING)
Carter Products
HIS
Apr 2, 1990K900360SAXON ULTRA THIN
Safetex Corp.
HIS
Apr 2, 1990K900359EMBRACE
Safetex Corp.
HIS
Apr 2, 1990K900358SAXON WET LUBE
Safetex Corp.
HIS
Apr 2, 1990K900357GOLD CIRCLE COIN
Safetex Corp.
HIS
Mar 27, 1990K901112G.S.A. COLORED CONDOMS
Ansell, Inc.
HIS
Mar 27, 1990K901111NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
Ansell, Inc.
HIS
Feb 16, 1990K896623SAFECON CONDOMS - PINK COLOR
Quality Synthetics Intl, Inc.
HIS

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