meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
42
Latest Decision
2014-10-30

Clearances · page 11 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140590 ASTROGLIDE SENSUAL STRAWBERRY Biofilm, Inc. NUC Class II 2014-10-30
K140754 COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM CooperSurgical, Inc. HEX Class II 2014-10-23
K132490 SKORE AND MULTIPLE BRANDS Ttk Protective Devices Limited (Formerly Ttk-Lig L HIS Class II 2014-10-20
K141742 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS Ardo Medical AG HGX Class II 2014-10-17
K133990 IEVA REHABILITATIVE POSITIONAL DEVICE Remendium Labs, LLC HIR Class II 2014-10-09
K140304 SIMPLY SLICK PERSONAL LUBRICATING LOTION Simply Solutions, LLC NUC Class II 2014-10-07
K142304 Viberect Penile Vibratory Stimulation Device Reflexonic, LLC KXQ Class II 2014-10-03
K140077 ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED Albaad , Ltd. HEB Class II 2014-09-22
K140780 KEGEL SMART, KEGELSMART PEARL Regulatory Insight, Inc. HIR Class II 2014-09-10
K141848 IOGYN SYSTEM Iogyn, Inc. PGT Class II 2014-08-29
K140862 MONICA NOVII WIRELESS PATCH SYSTEM Monica Healthcare, Ltd. OSP Class II 2014-08-27
K140305 CAYA CONTOURED DIAPHRAGM Kessel Medintim GmbH HDW Class II 2014-08-26
K141294 U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corp. HEB Class II 2014-08-25
K132772 LUBRIGYN CREAM Uniderm Farmaceutici Srl NUC Class II 2014-08-22
K133712 EMBRYOVIEWER SOFTWARE Unisense Fertilitech A/S MQG Class II 2014-08-08
K141365 OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN William A. Cook Australia Pty. , Ltd. MQE Class II 2014-08-07
K141581 ASTROGLIDE NATURAL Biofilm, Inc. NUC Class II 2014-08-06
K141059 NATURAL RUBBER LATEX MALE CONDOMS Karex Industries Sdn. Bhd. HIS Class II 2014-08-01
K133336 PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE Pjur Group Luxembourg S.A. NUC Class II 2014-07-24
K141256 OKAMOTO STUDDED CONDOM Okamoto USA, Inc. HIS Class II 2014-07-23
K141663 EEVA DISH (WITH 12 MICROWELLS) Auxogyn, Inc. MQK Class II 2014-07-22
K141034 AZUL PERSONAL LUBRICANT Church & Dwight Co., Inc. NUC Class II 2014-07-21
K133233 PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE Pjur Group Luxembourg S.A. NUC Class II 2014-07-18
K133568 G-TL Vitrolife, Inc. MQL Class II 2014-07-16
K140186 THE STORK OTC Rinovum Women'S Health, Inc. OBB Class II 2014-07-11
K140626 MELUNA CLASSIC/SPORT MENSTRUAL CUP Meluna HHE Class II 2014-07-10
K132384 U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA Endosec Corporation HIH Class II 2014-07-02
K140379 MEGA BIG BOY CONDOM Okamoto USA, Inc. HIS Class II 2014-07-01
K133799 THERMEDX FLUID MANAGMENT SYSTEM Thermedx, LLC HIG Class II 2014-06-20
K133295 QUALIS Menicon Co., Ltd. New Business Division MQK Class II 2014-06-18
K140317 EMBRYOGEN Origio A/S MQL Class II 2014-06-16
K132954 JO PREMIUM PERSONAL LUBRICANT United Consortium NUC Class II 2014-06-11
DEN120015 EEVA 2.0 Auxogyn, Inc. PBH Class II 2014-06-06
K132670 PANPAC INFLATABLE DOCUT PESSARY Panpac Medical Corporation HHW Class II 2014-06-04
K140163 KOALA TOCO Clinical Innovations, LLC HFM Class II 2014-05-29
K131781 CLEARVIEW TOTAL Clinical Innovations, LLC LKF Class II 2014-05-28
K132744 ACESSA GUIDANCE SYSTEM Halt Medical, Inc. HFG Class II 2014-05-27
K133257 BIOPSY PIPETTES Research Instruments , Ltd. MQH Class II 2014-05-16
K131941 FETAL MONITORS Guangdong Biolight Meditech Co., Ltd. HGM Class II 2014-05-15
K133912 ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO Origio A/S MQL Class II 2014-05-14
K132870 Origio Gas Line Filter Origio, Inc. MQG Class II 2014-05-07
K131866 SUSTAIN Hollender Sustainable Brands, LLC HIS Class II 2014-05-01
K133387 ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED Origio A/S MQL Class II 2014-04-29
K132184 ACESSA GUIDANCE HANDPIECE Halt Medical, Inc. HFG Class II 2014-04-28
K133857 BRELLA-SPEC(TM) VAGINAL SPECULUM Proa Medical, Inc. HIB Class II 2014-04-28
K132882 ELECTRIC BREAST PUMP Shantou Xinghe Electrical Apparatuses Co., Ltd. HGX Class II 2014-04-24
K131889 EUM 100PRO Promedic, Inc. OSP Class II 2014-04-23
K132595 ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS Ontex Bvba HEB Class II 2014-04-23
K133742 XQ-1 INCUBATOR At Medical Uab MQG Class II 2014-04-23
K132390 INSTINCT; PLAIN, DOTTED, ULTRA THIN Profilatex, S.A. DE C.V. HIS Class II 2014-04-22
K140761 KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA Carefusion 2200, Inc. HES Class II 2014-04-21
K133707 SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS Origio A/S MQL Class II 2014-04-16
K134047 JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS Integra LifeSciences Corporation HCZ Class II 2014-04-11
K132208 ONTEX AND OTHERS PROPRIETARY NAMES Ontex Bvba HIL Class II 2014-04-10
K132423 THE GYNOCULAR Gynius AB HEX Class II 2014-04-08
K140072 CRYOTOP(R) SC Kitazato Biopharma Co., Ltd. MQK Class II 2014-04-03
DEN130040 IOGYN SYSTEM Iogyn, Inc. PGT Class II 2014-03-28
K133144 SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE Crossbay Medical, Inc. PGK Class II 2014-03-19
K132107 MALE LATEX CONDOM Nulatex Sdn. Bhd. HIS Class II 2014-03-07
K140263 INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT Lexion Medical, LLC HIF Class II 2014-03-05
K131145 PROINSERT Nidacon International AB MQK Class II 2014-02-20
K132650 SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM Huntleigh Healthcare Limited HGM Class II 2014-02-07
K132135 LINA GOLD LOOP HC Lina Medical Aps KNF Class II 2014-01-31
K131457 FETAL ULTRASONIC MONITOR AND ACCESSORIES Shenzhen Jumper Medical Equipment Co., Ltd. KNG Class II 2014-01-24
K132668 IOB DISPOSABLE SPECULUM Iob Medical, Inc. HIB Class II 2014-01-17
K130087 PANPAC WORD/BARTHOLIN CATHETER Panpac Medical Corporation KNA Class II 2014-01-10
K122982 CRYOLOCK Biotech, Inc. MQK Class II 2014-01-09
K133244 TAMPAX M PLASTIC TAMPONS, UNSCENTED The Procter & Gamble Company HEB Class II 2014-01-09
K130606 FMWAND FERROMAGNETIC SURGICAL SYSTEM Domain Surgical, Inc. HGI Class II 2014-01-03
K132015 TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS Smith & Nephew, Inc. HIH Class II 2013-12-13
K130758 KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER Kronner Prototypes, Inc. LKF Class II 2013-12-11
K132597 BLACK COLOURED CONDOM Karex Industries Sdn. Bhd. HIS Class II 2013-11-25
K132918 SENSE-4BABY SYSTEM Sense4baby , Inc. HGM Class II 2013-11-22
K122061 K-Y BRAND LIQUIBEADS Johnson & Johnson Healthcare Products NUC Class II 2013-11-08
K131355 CONCEIVE PLUS Sasmar, Inc. PEB Class II 2013-11-07
K131887 TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT Church & Dwight Co., Inc. HIS Class II 2013-10-24
K132819 PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS Playtex Manufacturing, Inc. HIL Class II 2013-10-09
K122800 INNER PEACE Kamabry, Inc., Dba Inner Peace For Women HIR Class II 2013-10-04
K131206 COOK CERVICAL RIPENING BALLOON Cook, Inc. PFJ Class II 2013-09-27
K122219 THEYFIT MALE CONDOM Theyfit HIS Class II 2013-09-27
K131656 MORCELLEX SIGMA GENERATOR ETHICON, Inc. HET Class II 2013-09-27
K132203 PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA Lexion Medical, LLC HIF Class II 2013-09-20
K122311 GC-3000E DIGITAL COLPOSCOPE Shenzhen Goldcare Meditech Co., Ltd. HEX Class II 2013-09-18
K131084 SASMAR ORIGINAL, SASMAR CLASSIC Sasmar, Inc. NUC Class II 2013-09-13
K131491 KITAZATO IUI CATHETER Kitazato Medical Co., Ltd. MQF Class II 2013-09-11
K130349 FREEMIE BREAST COLLECTION SYSTEM Dao Health HGX Class II 2013-09-06
K124044 ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS Seven Oaks Ranch, Inc. NUC Class II 2013-08-30
K131198 TIPI OTC Contipi , Ltd. HHW Class II 2013-08-27
K131736 MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) Hologic, Inc. HIH Class II 2013-08-22
K132204 INSUFLOW SYNERGY XL PORT Lexion Medical, LLC HIF Class II 2013-08-22
K131581 MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) Hologic, Inc. HIH Class II 2013-08-22
K130012 WET PLATINUM PERSONAL LUBRICANT Trigg Laboratories, Inc. NUC Class II 2013-08-22
K130273 PANPAC VAGINAL DILATORS Panpac Medical Corporation HDX Class II 2013-08-08
K130046 CLEARSPEC SINGLE USE VAGINAL SPECULUM Clearspec, LLC HIB Class II 2013-08-06
K130345 AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING Mayer Laboratories, Inc. NUC Class II 2013-08-01
K130059 ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP Ibi Israel Biomedical Innovations , Ltd. PBQ Class II 2013-07-29
K130305 LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE Lina Medical Aps HIN Class II 2013-07-24
K123641 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH Hertart MQK Class II 2013-07-03
K130002 SURECALL LABOR MONITOR Reproductive Research Technologies, LP OSP Class II 2013-06-28
K123427 NIRVANA D PERSONAL LUBRICANT (TBD) Church & Dwight Co., Inc. NUC Class II 2013-06-28

4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.