meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
37
Latest Decision
2013-06-26

Clearances · page 12 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K122983 KSEA BIPOLAR ELECTRODE KARL STORZ Endoscopy-America, Inc. HIN Class II 2013-06-26
K131373 SHANGRING Wuhu Snnda Medical Treatment Appliance Technology HFX Class II 2013-06-25
K131543 TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED Procter & Gamble Co. HEB Class II 2013-06-20
K122820 VIKY UP Endocontrol LKF Class II 2013-06-18
K131153 EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP Evenflo Feeding Incorporated HGX Class II 2013-06-18
K121343 MODULAP LOOP Atc Technologies, Inc. KNF Class II 2013-06-14
K122973 AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE Medgyn Products, Inc. HEX Class II 2013-06-12
K121902 NATRATONE Orelle Corporation, Ltd. HIR Class II 2013-06-06
K131027 MEMORY PUMP MODEL Y4947 Tomy International HGX Class II 2013-05-30
K123770 WARMING JELLY PERSONAL LUBRICANT Wisconsin Pharmacal Co., LLC NUC Class II 2013-04-09
K130006 BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS Cook Biotech Incorporated PAI Class III 2013-04-05
K121478 NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP Mapa GmbH HGX Class II 2013-04-05
K123732 HYSTEROSCOPY PUMP HM6 W.O.M. World of Medicine AG HIG Class II 2013-04-04
K130609 VEEDA 100% COTTON MENSTRUAL TAMPON Naturalena Brands, Inc. HEB Class II 2013-03-21
K123335 SUNRAY FETAL MONITOR Sunray Medical Apparatus Co., Ltd. HGM Class II 2013-03-21
K123330 IOGYN ENDOSCOPE Iogyn, Inc. HIH Class II 2013-03-19
K123151 ENDOSEE MODEL 8000 U-SCOPE Endosee Corp HIH Class II 2013-03-08
K122476 LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT Ansell Healthcare Products, LLC NUC Class II 2013-03-07
K123365 OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 Olympus Medical Systems Corp. HET Class II 2013-03-01
K122720 LIFESTYLES WARM LOVIN PERSONAL LUBRICANT Ansell Healthcare Products, LLC NUC Class II 2013-02-22
K122477 LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT Ansell Healthcare Products, LLC NUC Class II 2013-02-19
K122054 LIFESTYLES NATURAL PERSONAL LUBRICANT Ansell Healthcare Products, LLC NUC Class II 2013-02-14
K121241 MALE LATEX CONDOM Nulatex Sdn. Bhd. HIS Class II 2013-02-14
K123258 THE ADVANCE CATHETER FOR HSG AND SIS Catheter Research, Inc. LKF Class II 2013-01-31
K122474 LANSINOH POWERED ELECTRIC BREAST PUMP Lansinoh Laboratories Saglik Gerecleri Tasarim San HGX Class II 2012-12-28
K122658 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 Femasys, Inc. PCF Class II 2012-12-20
K122603 ONTEX AND OTHER PROPRIETARY NAMES Ontex Bvba HEB Class II 2012-12-19
K112644 SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM Lotus Bio, Ltd. MQK Class II 2012-12-19
K122459 PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM Boston Scientific Corporation OTP Class III 2012-12-13
K112695 CRYOTOP Kitazato Biopharma Co;Ltd MQK Class II 2012-12-12
K122605 PKS BILL Gyrus Acmi, Inc. HIN Class II 2012-12-05
K121566 PLANER BT37 INCUBATOR Planer Plc MQG Class II 2012-11-29
K112462 KITAZATO OPU NEEDLE Kitazato Medical Co., Ltd. MQE Class II 2012-11-26
K113315 RUMBLE TUFF Acute Ideas Co. , Ltd. HGX Class II 2012-11-20
K121857 FEMMYCYCLE Femcap Incorporated HHE Class II 2012-11-15
K122180 HIGH FLOW INSUFFLANTION UNIT Olympus Medical Systems Corporation HIF Class II 2012-11-13
K121858 THE ABLATION SYSTEM Halt Medical, Inc. HFG Class II 2012-11-05
K112396 IUI CATHETERS Kitazato Medical Co., Ltd. MQF Class II 2012-11-02
K120555 LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) Medical-Latex (Dua) Sdn. Bhd HIS Class II 2012-11-02
K113786 SPERMFREEZE SOLUTION Vitrolife Sweden AB MQL Class II 2012-10-26
K121881 DOMAIN SURGICAL SYSTEM Domain Surgical, Inc. HGI Class II 2012-10-18
K112217 ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER Polichem S.A NUC Class II 2012-10-16
K120831 ANCHORSURE Neomedic International S.L. PBQ Class II 2012-10-12
K121758 CERNER FETALINK+(VERSION1.0) Cerner Corp. HGM Class II 2012-10-09
K120706 NIRVANA A PERSONAL LUBRICANT Church & Dwight Co., Inc. NUC Class II 2012-10-04
K120751 NIRVANA B PERSONAL LUBRICANT Church & Dwight Co., Inc. NUC Class II 2012-10-03
K120136 EMBRYOGEN Origio A/S MQL Class II 2012-09-26
K120018 MINDCHILD MERIDIAN FETAL HEART RATE MONITOR Mindchild Medical HGM Class II 2012-09-19
K122563 MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL Hologic, Inc. HIH Class II 2012-09-19
K120107 SCKOONCUP Sckoon, Inc. HHE Class II 2012-09-18
K122498 MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) Hologic, Inc. HIH Class II 2012-09-10
K112200 FOCUS TOUCH CONCEPTION SYSTEM Intimate Bridge 2 Conception, Inc. OBB Class II 2012-09-06
K120151 NEBULAE I Northgate Technologies, Inc. HIF Class II 2012-08-17
K121789 SHANGRING Wuhu Snna Medical Treatment Appliance Technology C HFX Class II 2012-08-03
K121267 BT-200V VASCULAR DOPPLER Bistos Co., Ltd. HGM Class II 2012-08-02
K121612 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION American Medical Systems OTP Class III 2012-07-20
K121572 CONTINUOUS SINGLE CULTURE COMPLETE Irvine Scientific Sales Co., Inc. MQL Class II 2012-07-19
K121868 MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) Hologic, Inc. HIH Class II 2012-07-19
K120640 INSUFLOW SYNERGY PORT Lexion Medical, LLC HIF Class II 2012-07-18
K112390 MONICA AN24 Monica Healthcare, Ltd. OSP Class II 2012-07-13
K120481 LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, Tosama, D.O.O. HEB Class II 2012-07-13
K112413 RI MSC (MIGRATION SEDIMENTATION CHAMBER) Research Instruments , Ltd. MQK Class II 2012-07-13
K111014 LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES Lsi Solutions, Inc. HEW Class II 2012-07-13
K120650 POISE PERSONAL LUBRICANT Kimberly-Clark Corporation NUC Class II 2012-07-11
K113056 ORANGE COLORED CONDOMS ORANGE SCENT Karex Industries Sdn. Bhd. HIS Class II 2012-07-03
K121336 MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 Surgiquest, Inc. HIF Class II 2012-07-03
K113080 TUBALGATOR Mectra Labs, Inc. HIN Class II 2012-06-29
K112975 CARBONAID C02 DIFFUSER Cardia Innovation AB HIF Class II 2012-06-22
K120245 PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS Playtex, Inc. HIL Class II 2012-06-21
K120877 MICROMANIPULATOR SET Narishige Co., Ltd. MQJ Class II 2012-06-20
K120286 TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT Church & Dwight Co., Inc. HIS Class II 2012-06-19
K112763 MATRIXBRUSH ENDOMETRIAL SAMPLER Post Oak Innovations, Inc. HFE Class II 2012-06-18
K121208 OBIX PERINATAL DATA SYSTEM 7.0 Clinical Computer Systems, Inc. HGM Class II 2012-06-14
K121128 MULTIPURPOSE HANDLING MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2012-06-06
K121322 CLOSER TO NATURE Mayborn Group Limited HGX Class II 2012-05-31
K112165 RHEA CUP Apex Medical Technologies, Inc. HHE Class II 2012-05-24
K120287 TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT Church & Dwight Co., Inc. HIS Class II 2012-05-16
K120249 TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT Church & Dwight Virginia Co., Inc. HIS Class II 2012-05-11
K112856 LUCINA-MELODI Genadyne Biotechnologies, Inc. HGX Class II 2012-05-10
K120394 LIFESTYLES ZERO LUBRICATED LATEX CONDOM Ansell Heathcare Products, LLC HIS Class II 2012-05-08
K112083 LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES <Genx> Intl., Inc. MQL Class II 2012-05-03
K120055 HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS Hamilton Thorne, Inc. MRX Class II 2012-04-24
K111425 OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 Olympus Medical Systems Corp. HET Class II 2012-04-20
K110690 ONE PERSONAL LUBRICANT (SILICONE) One NUC Class II 2012-03-28
K120743 SPECULUM, VAGINAL, NONMETAL Welch Allyn, Inc. HIB Class II 2012-03-23
K120593 MYOSURE CONTROL UNIT Hologic, Inc. HIH Class II 2012-03-23
K120154 INTRAUTERINE INSEMINATION (IUI) CATHETER Catheter Research, Inc. MQF Class II 2012-03-21
K113712 IM-11 PNEUMATIC MICROINJECTOR Narishige Co., Ltd. MQJ Class II 2012-03-15
K113686 KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED Mayer Laboratories, Inc. HIS Class II 2012-03-06
K113664 CLOSER TO NATURE ELECTRIC BREAST PUMP Mayborn Group Limited HGX Class II 2012-02-17
K113259 NOTOUCH BREASTSCAN Ue Lifesciences, Inc. LHQ Class I 2012-02-10
K103726 JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS Integra LifeSciences Corporation KNF Class II 2012-02-08
K112642 AQUILEX FLUID CONTROL SYSTEM H112 W.O.M. World of Medicine AG HIG Class II 2012-02-06
K111684 PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD Playtex Manufacturing, Inc. HIL Class II 2012-02-03
K111411 FREEMIE (R) Dao Health HGX Class II 2012-02-01
K110691 ONE PERSONAL LUBRICANT (WATER BASED) One NUC Class II 2012-02-01
K111681 HISTOBRUSH Puritan Medical Products Company, LLC HHT Class II 2012-01-19
K111788 ENDOEYE HD II Olympus America, Inc. HET Class II 2012-01-13
K113699 TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED The Procter & Gamble Company HEB Class II 2012-01-12
K103695 PREPEX SYSTEM Circ Medtech HFX Class II 2012-01-10

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