Atlas FDA

Obstetrics/Gynecology

4,608 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE (K133336)Pjur Group Luxembourg S.A.2014-07-24
OKAMOTO STUDDED CONDOM (K141256)Okamoto USA, Inc.2014-07-23
EEVA DISH (WITH 12 MICROWELLS) (K141663)Auxogyn, Inc.2014-07-22
AZUL PERSONAL LUBRICANT (K141034)Church & Dwight Co., Inc.2014-07-21
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE (K133233)Pjur Group Luxembourg S.A.2014-07-18
G-TL (K133568)Vitrolife, Inc.2014-07-16
THE STORK OTC (K140186)Rinovum Women'S Health, Inc.2014-07-11
MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626)Meluna2014-07-10
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA (K132384)Endosec Corporation2014-07-02
MEGA BIG BOY CONDOM (K140379)Okamoto USA, Inc.2014-07-01
THERMEDX FLUID MANAGMENT SYSTEM (K133799)Thermedx, LLC2014-06-20
QUALIS (K133295)Menicon Co., Ltd. New Business Division2014-06-18
EMBRYOGEN (K140317)Origio A/S2014-06-16
JO PREMIUM PERSONAL LUBRICANT (K132954)United Consortium2014-06-11
EEVA 2.0 (DEN120015)Auxogyn, Inc.2014-06-06
PANPAC INFLATABLE DOCUT PESSARY (K132670)Panpac Medical Corporation2014-06-04
KOALA TOCO (K140163)Clinical Innovations, LLC2014-05-29
CLEARVIEW TOTAL (K131781)Clinical Innovations, LLC2014-05-28
ACESSA GUIDANCE SYSTEM (K132744)Halt Medical, Inc.2014-05-27
BIOPSY PIPETTES (K133257)Research Instruments , Ltd.2014-05-16
FETAL MONITORS (K131941)Guangdong Biolight Meditech Co., Ltd.2014-05-15
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO (K133912)Origio A/S2014-05-14
Origio Gas Line Filter (K132870)Origio, Inc.2014-05-07
SUSTAIN (K131866)Hollender Sustainable Brands, LLC2014-05-01
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED (K133387)Origio A/S2014-04-29
BRELLA-SPEC(TM) VAGINAL SPECULUM (K133857)Proa Medical, Inc.2014-04-28
ACESSA GUIDANCE HANDPIECE (K132184)Halt Medical, Inc.2014-04-28
ELECTRIC BREAST PUMP (K132882)Shantou Xinghe Electrical Apparatuses Co., Ltd.2014-04-24
XQ-1 INCUBATOR (K133742)At Medical Uab2014-04-23
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS (K132595)Ontex Bvba2014-04-23
EUM 100PRO (K131889)Promedic, Inc.2014-04-23
INSTINCT; PLAIN, DOTTED, ULTRA THIN (K132390)Profilatex, S.A. DE C.V.2014-04-22
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (K140761)Carefusion 2200, Inc.2014-04-21
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS (K133707)Origio A/S2014-04-16
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS (K134047)Integra LifeSciences Corporation2014-04-11
ONTEX AND OTHERS PROPRIETARY NAMES (K132208)Ontex Bvba2014-04-10
THE GYNOCULAR (K132423)Gynius AB2014-04-08
CRYOTOP(R) SC (K140072)Kitazato Biopharma Co., Ltd.2014-04-03
IOGYN SYSTEM (DEN130040)Iogyn, Inc.2014-03-28
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (K133144)Crossbay Medical, Inc.2014-03-19
MALE LATEX CONDOM (K132107)Nulatex Sdn. Bhd.2014-03-07
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT (K140263)Lexion Medical, LLC2014-03-05
PROINSERT (K131145)Nidacon International AB2014-02-20
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM (K132650)Huntleigh Healthcare Limited2014-02-07
LINA GOLD LOOP HC (K132135)Lina Medical Aps2014-01-31
FETAL ULTRASONIC MONITOR AND ACCESSORIES (K131457)Shenzhen Jumper Medical Equipment Co., Ltd.2014-01-24
IOB DISPOSABLE SPECULUM (K132668)Iob Medical, Inc.2014-01-17
PANPAC WORD/BARTHOLIN CATHETER (K130087)Panpac Medical Corporation2014-01-10
TAMPAX M PLASTIC TAMPONS, UNSCENTED (K133244)The Procter & Gamble Company2014-01-09
CRYOLOCK (K122982)Biotech, Inc.2014-01-09
FMWAND FERROMAGNETIC SURGICAL SYSTEM (K130606)Domain Surgical, Inc.2014-01-03
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS (K132015)Smith & Nephew, Inc.2013-12-13
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER (K130758)Kronner Prototypes, Inc.2013-12-11
BLACK COLOURED CONDOM (K132597)Karex Industries Sdn. Bhd.2013-11-25
SENSE-4BABY SYSTEM (K132918)Sense4baby , Inc.2013-11-22
K-Y BRAND LIQUIBEADS (K122061)Johnson & Johnson Healthcare Products2013-11-08
CONCEIVE PLUS (K131355)Sasmar, Inc.2013-11-07
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT (K131887)Church & Dwight Co., Inc.2013-10-24
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (K132819)Playtex Manufacturing, Inc.2013-10-09
INNER PEACE (K122800)Kamabry, Inc., Dba Inner Peace For Women2013-10-04
THEYFIT MALE CONDOM (K122219)Theyfit2013-09-27
MORCELLEX SIGMA GENERATOR (K131656)ETHICON, Inc.2013-09-27
COOK CERVICAL RIPENING BALLOON (K131206)Cook, Inc.2013-09-27
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (K132203)Lexion Medical, LLC2013-09-20
GC-3000E DIGITAL COLPOSCOPE (K122311)Shenzhen Goldcare Meditech Co., Ltd.2013-09-18
SASMAR ORIGINAL, SASMAR CLASSIC (K131084)Sasmar, Inc.2013-09-13
KITAZATO IUI CATHETER (K131491)Kitazato Medical Co., Ltd.2013-09-11
FREEMIE BREAST COLLECTION SYSTEM (K130349)Dao Health2013-09-06
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS (K124044)Seven Oaks Ranch, Inc.2013-08-30
TIPI OTC (K131198)Contipi , Ltd.2013-08-27
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) (K131581)Hologic, Inc.2013-08-22
INSUFLOW SYNERGY XL PORT (K132204)Lexion Medical, LLC2013-08-22
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) (K131736)Hologic, Inc.2013-08-22
WET PLATINUM PERSONAL LUBRICANT (K130012)Trigg Laboratories, Inc.2013-08-22
PANPAC VAGINAL DILATORS (K130273)Panpac Medical Corporation2013-08-08
CLEARSPEC SINGLE USE VAGINAL SPECULUM (K130046)Clearspec, LLC2013-08-06
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING (K130345)Mayer Laboratories, Inc.2013-08-01
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP (K130059)Ibi Israel Biomedical Innovations , Ltd.2013-07-29
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (K130305)Lina Medical Aps2013-07-24
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH (K123641)Hertart2013-07-03
SURECALL LABOR MONITOR (K130002)Reproductive Research Technologies, LP2013-06-28
NIRVANA D PERSONAL LUBRICANT (TBD) (K123427)Church & Dwight Co., Inc.2013-06-28
KSEA BIPOLAR ELECTRODE (K122983)KARL STORZ Endoscopy-America, Inc.2013-06-26
SHANGRING (K131373)Wuhu Snnda Medical Treatment Appliance Technology2013-06-25
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (K131543)Procter & Gamble Co.2013-06-20
VIKY UP (K122820)Endocontrol2013-06-18
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP (K131153)Evenflo Feeding Incorporated2013-06-18
MODULAP LOOP (K121343)Atc Technologies, Inc.2013-06-14
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE (K122973)Medgyn Products, Inc.2013-06-12
NATRATONE (K121902)Orelle Corporation, Ltd.2013-06-06
MEMORY PUMP MODEL Y4947 (K131027)Tomy International2013-05-30
WARMING JELLY PERSONAL LUBRICANT (K123770)Wisconsin Pharmacal Co., LLC2013-04-09
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (K130006)Cook Biotech Incorporated2013-04-05
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP (K121478)Mapa GmbH2013-04-05
HYSTEROSCOPY PUMP HM6 (K123732)W.O.M. World of Medicine AG2013-04-04
VEEDA 100% COTTON MENSTRUAL TAMPON (K130609)Naturalena Brands, Inc.2013-03-21
SUNRAY FETAL MONITOR (K123335)Sunray Medical Apparatus Co., Ltd.2013-03-21
IOGYN ENDOSCOPE (K123330)Iogyn, Inc.2013-03-19
ENDOSEE MODEL 8000 U-SCOPE (K123151)Endosee Corp2013-03-08
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT (K122476)Ansell Healthcare Products, LLC2013-03-07
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