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 23, 1990K895640MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
Armkel, LLC
HIS
Jan 16, 1990K895091RIA (CONDOM)
La Technology Sdn. Bhd., MY
HIS
Jan 10, 1990K896339MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
Okamoto USA, Inc.
HIS
Jan 10, 1990K893217LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
Shinhen Corp.
HIS
Dec 18, 1989K894533CONDOM (RUBBER LATEX) KILROY
Rfsu, SE
HIS
Dec 14, 1989K895894PROFIL CONDOM (RUBBER LATEX)
Rfsu, SE
HIS
Dec 14, 1989K895028BIRDS'N BEES CONDOMS
Rfsu, SE
HIS
Dec 14, 1989K894534CONDOM (RUBBER LATEX) OKEIDO
Rfsu, SE
HIS
Nov 28, 1989K895530STANDARD CONDOM
Mayer Laboratories
HIS
Sep 12, 1989K884692THE SAFEGARD PERSONAL PROTECTION KIT
The Safegard Protection Corp.
HIS
Aug 11, 1989K880819CONDOMS
Universal Trade, Inc.
HIS
Jun 23, 1989K884925THE GREAT WALL CONDOM
Pacific Sales & Development Corp.
HIS
Jun 20, 1989K890819HSV-CHECK(TM) TEST KIT
Diagnostic Technology, Inc.
HIS
May 16, 1989K890407THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
Circle Rubber Corp.
HIS
Apr 25, 1989K884454SAFECON CONDOMS - RIBBED
Quality Synthetics Intl, Inc.
HIS
Apr 4, 1989K890863TROJAN FOR WOMEN
Armkel, LLC
HIS
Mar 31, 1989K884470KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
Mayer Laboratories
HIS
Mar 31, 1989K884469ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
Mayer Laboratories
HIS
Mar 31, 1989K884468SUPER MAXX OTHERS (MULTIPLE) CONDOMS
Mayer Laboratories
HIS
Mar 29, 1989K883524SAFECON CONDOMS W/SPERMICIDAL LUBRICANT
Quality Synthetics Intl, Inc.
HIS
Mar 13, 1989K883409AEGIS(TM) CONDOMS
Green Cross Medical Supplies Corp., KR
HIS
Mar 10, 1989K884402EXTRA STRENGTH SKIN LESS SKIN CONDOM
Okamoto USA, Inc.
HIS
Mar 1, 1989K884399STANDARD LATEX CONDOM
Schmid Laboratories, Inc.
HIS
Mar 1, 1989K871358SENSATIONS BRAND CONDOMS
Apex Medical Technologies, Inc.
HIS
Jan 12, 1989K884401SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
Okamoto USA, Inc.
HIS
Dec 8, 1988K883413TROJAN EXTRA STRENGTH LUBRICATED
Carter Products
HIS
Oct 26, 1988K883467THE SAXON SPERMICIDAL CONDOM
Circle Rubber Corp.
HIS
Oct 26, 1988K882893CONDOMS (RAMSES, SHEIK AND KOROMEX)
Schmid Laboratories, Inc.
HIS
Oct 20, 1988K882389KISS OF MINT(TM) NON-LUBRICATED CONDOM
Ansell, Inc.
HIS
Sep 21, 1988K882009KING KONDOM (CONDOM)
King Kondom Products, Inc., CA
HIS
Jul 8, 1988K881100CONDOM
Glnic Corp.
HIS
Jul 5, 1988K881735CONDOM
Iris Medical Ent., Inc.
HIS
Jul 1, 1988K874236APOLLO CONDOM
Apollo Enterprise, Ltd. Co.
HIS
Jun 29, 1988K880919(CHOICE) ALSO (KONDUM)
Select Sources, Inc.
HIS
Jun 27, 1988K880189NEW JELLIACOAT
K&G Import/Export Co.
HIS
Jun 21, 1988K880820OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED
Schmid Laboratories, Inc.
HIS
Jun 17, 1988K880185DUET (CONDOMS)
American Laboratories, Inc.
HIS
Jun 13, 1988K880463CONDOM (PROPHYLACTIC)
Health Technologies Intl.
HIS
May 13, 1988K874921HEADFIRST (CONDOM)
Stual Products, Inc.
HIS
May 10, 1988K875068AIDS SAFETY BELT
Aids Safety Belt, Inc.
HIS
Apr 12, 1988K874791CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)
Schmid Laboratories, Inc.
HIS
Apr 12, 1988K871267BLAUSIEGEL TRANSPARENT CONDOMS
Ticosan, Inc.
HIS
Apr 6, 1988K874399SAFECON CONDOMS
Quality Synthetics Intl, Inc.
HIS
Apr 6, 1988K872356CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)
Mayer Laboratories
HIS
Mar 9, 1988K871744CONTATTO CONDOMS
Razi Corp.
HIS
Mar 7, 1988K874383MENTOR PLUS (CONDOM)
Arcon Corp.
HIS
Feb 26, 1988K880202OKAMOTO CONDOMS
Schmid Laboratories, Inc.
HIS
Feb 26, 1988K875111RUBBER CONTRACEPTIVE, LATEX CONDOMS
Okamoto USA, Inc.
HIS
Jan 21, 1988K874851XL-4 PAGODA (CONDOMS)
Mayer Laboratories
HIS
Jan 19, 1988K874135CONDOM (PROPHYLACTIC)
Pactec, Inc.
HIS

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