meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
37
Latest Decision
2007-03-14

Clearances · page 16 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063227 CONCEIVEX CONCEPTION KIT Conceivex, Inc. OBB Class II 2007-03-14
K063712 AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. Bard, Inc. OTP Class III 2007-03-12
K060764 SATURN 3 LASER SYSTEM Research Instruments , Ltd. MRX Class II 2007-03-12
K063562 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS ETHICON, Inc. OTP Class III 2007-02-26
K061309 EMBRYOASSIST Medicult A/S MQL Class II 2007-02-08
K062535 K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING Mcneil-Ppc, Inc. NUC Class II 2007-01-26
K063429 GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 Generic Medical Device, Inc. HFX Class II 2007-01-17
K063546 INSUFLOW DEVICE, MODEL 6198 Lexion Medical, LLC HIF Class II 2007-01-10
K060852 MOONCUP Mooncup Limited HHE Class II 2006-12-26
K062524 OCTAX LASER SHOT SYSTEM Minitube of America, Inc. MRX Class II 2006-12-15
K062796 K-Y BRAND INTRIGUE Personal Products Co. NUC Class II 2006-12-08
K062001 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HEB Class II 2006-12-07
K061466 INTIMOL Dlc Laboratories, Inc. NUC Class II 2006-12-04
K062638 TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS Procter & Gamble Co. HEB Class II 2006-11-22
K062438 BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 Cook Ob/Gyn KNA Class II 2006-10-27
K061651 FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 Apple Medical Corp. HGI Class II 2006-10-20
K063047 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM Medhot Thermal Imaging, Inc. LHQ Class I 2006-10-19
K061679 WALLACE ARTIFICIAL INSEMINATION CATHETER Irvine Scientific Sales Co., Inc. LKF Class II 2006-10-13
K062097 VERESS CANNULA AND MODULAR VERESS CANNULA PAJUNK GmbH Medizintechnologie HET Class II 2006-10-13
K051436 PRE' VAGINAL LUBRICANT Ingfertlity, LLC PEB Class II 2006-10-13
K050197 MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 Minitube of America, Inc. MQG Class II 2006-10-06
K062730 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS Biogreen Medical Sdn. Bhd. HIS Class II 2006-10-05
K061145 SPERMSLOW Medicult A/S MQL Class II 2006-10-02
K061339 HIERSPEC SPECULUM Medical Products Div. HIB Class II 2006-09-19
K052206 ZEUS MALE CONDOM APPLICATOR Condax, LLC HIS Class II 2006-09-12
K062137 MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH HGM Class II 2006-08-24
K062169 APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS Applied Medical Resources Corp. HET Class II 2006-08-24
K061371 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER Cook Urological, Inc. MQL Class II 2006-08-17
K061013 PLAYTEX EMBRACE PETITE BREAST PUMP Playtex Products, Inc. HGX Class II 2006-08-15
K061306 CO-1000 COLPOSCOPE, MULTIPLE Gynex Corp. HEX Class II 2006-08-07
K061486 TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) Procter & Gamble Co. HEB Class II 2006-08-01
K061268 G-LIX TISSUE GRASPER Usgi Medical HET Class II 2006-07-31
K060320 FEMECC ENDOCERVICAL CURETTE Femspec LLC PCF Class II 2006-07-28
K060983 BIOPSY MEDIUM, MODEL REF 1062 Medicult A/S MQL Class II 2006-07-28
K061387 VERESURE BELL Veresure, Inc. HIF Class II 2006-07-21
K061050 GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R ETHICON, Inc. HET Class II 2006-07-14
K053646 INVITRO MATURATION MEDIA Sage In-Vitro Fertilization, Inc. MQL Class II 2006-07-14
K051688 FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS Trimensa Pharmaceuticals NUC Class II 2006-07-12
K061044 FEATHERLITE AQUA TOCODYNAMOMETER Ventrex, Inc. HFM Class II 2006-07-12
K060289 EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 Frontline Medical KNA Class II 2006-07-07
K060908 SONOHYSTEROGRAPHY BIOPSY DEVICE Cook Urological, Inc. PGK Class II 2006-06-29
K060526 TIPI Contipi , Ltd. HHW Class II 2006-06-09
K060098 DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS Ssl Americas, Inc. NUC Class II 2006-06-08
K060723 40 L HIGH FLOW INSUFFLATOR F113 W.O.M. World of Medicine AG HIF Class II 2006-05-25
K053552 GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA <Genx> Intl., Inc. MQL Class II 2006-05-19
K060699 SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) Medicult A/S MQL Class II 2006-05-10
K060981 PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS Playtex Products, Inc. HIL Class II 2006-05-09
K053551 MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL <Genx> Intl., Inc. MQL Class II 2006-05-09
K061091 BABYBEAT CORDLESS The Newman Group, LLC KNG Class II 2006-05-04
K060129 IGS VAGINAL SPECULUM Innovative Gynecological Solutions, LLC HIB Class II 2006-05-04
K053052 MEDELA SWING BREAST PUMP Medela AG HGX Class II 2006-05-02
K060168 VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT Irvine Scientific Sales Co., Inc. MQL Class II 2006-04-24
K060573 BURBANK TENACULUM Vascular Control Systems, Inc. HDC Class II 2006-04-21
K060145 FDS INTIMATE AND INTIMATE WARMING LUBRICANT Alberto-Culver USA, Inc. NUC Class II 2006-04-14
K051842 GREEN LOVE MALE CONTRACEPTIVE (CONDOM) Cupid Condom, Ltd. HIS Class II 2006-04-14
K052457 PICSI SPERM SELECTION DEVICE Biocoat, Inc. MQK Class II 2006-04-13
K050826 FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS Cetro America HGM Class II 2006-04-10
K060410 ECHOHEART TRANSVAGINAL DOPPLER PROBE Summit Doppler Systems, Inc. HEK Class II 2006-04-10
K060797 NAKED Veraxis Int'L, Inc. HIS Class II 2006-04-07
K052420 G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM Gynova, LLC HIB Class II 2006-04-06
K050913 DICK'S FORMALWEAR MALE LATEX CONDOM Dick'S Formalwear, Inc. HIS Class II 2006-04-04
K053583 OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL Optivia Medical, LLC HIH Class II 2006-03-31
K053494 OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE Fertipro NV MQL Class II 2006-03-23
K060230 DOPPLEX CENTRALE Huntleigh Healthcare , Ltd. HGM Class II 2006-03-23
K050239 EMD THERMOGRAPHY SYSTEM Em Diagnostics, Inc. LHQ Class I 2006-03-16
K050828 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. MOL Class II 2006-02-28
K053367 MALE NATURAL RUBBER LATEX CONDOM Innolatex Sdn. Bhd HIS Class II 2006-02-21
K053397 K-Y BRAND SENSUAL MIST Mcneil-Ppc, Inc. NUC Class II 2006-02-17
K051175 CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION Civent Communications, Ltd. HGM Class II 2006-02-17
K051295 I-D GLIDE Westridge Laboratories, Inc. NUC Class II 2006-02-15
K052125 CARBONAID GAS DIFFUSER Cardia Innovation AB HIF Class II 2006-02-08
K052162 SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT Sheffield Laboratories, Div. of Faria Limited, LLC NUC Class II 2006-02-06
K051288 VIELLE LUBRICANT Cst Medical Limited HIS Class II 2006-02-03
K052192 FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I Femspec LLC HIB Class II 2006-02-02
K053208 CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET Swemed Lab International AB MQF Class II 2006-01-30
K052959 DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS Ssl Americas HIS Class II 2006-01-27
K052795 PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH HGM Class II 2005-12-30
K051290 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) Procter & Gamble Co. HEB Class II 2005-12-27
K053414 MENTOR NOVASILK MESH Mentor Corp. OTP Class III 2005-12-27
K052715 CALM CURVE, VERSION 01.00 Lms Medical Systems (Canada), Ltd. HGM Class II 2005-12-22
K051294 FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 Femspec LLC HHK Class II 2005-12-21
K052974 WARMING LIQUID PERSONAL LUBRICANT Pharmapac, LLC NUC Class II 2005-12-16
K043598 FC 1400 FETAL MONITOR Bionet Co., Ltd. HGM Class II 2005-12-16
K043597 FC 700 FETAL MONITOR Bionet Co., Ltd. HGM Class II 2005-12-16
K052912 YUSHENG DISPOSABLE VAGINAL SPECULUM Zhejiang Yusheng Medical Instrument Co. , Ltd. HIB Class II 2005-12-15
K051926 LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP Limerick, Inc. HGX Class II 2005-12-12
K052059 IUI CATHETER, MODEL 9057 Inntec, Inc. MQF Class II 2005-11-22
K052314 DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE Dynarex Corp. HIB Class II 2005-11-09
K052909 EVENFLO ELAN BREAST PUMP Evenflo Company, Inc. HGX Class II 2005-11-01
K052365 CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE Rocket Medical Plc HEE Class II 2005-10-17
K051742 OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH Inntec, Inc. MQE Class II 2005-10-07
K052190 FETAL MONITOR, MODELS BT-300 AND BT-200 Bistos Co., Ltd. HGM Class II 2005-10-04
K052047 ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 Avent America, Inc. HGX Class II 2005-09-22
K041952 ZIVF-AIRE Zander Medical Supplies, Inc. MQG Class II 2005-09-08
K051112 WHITTLESTONE EXPRESSER Whittlestone, Inc. HGX Class II 2005-09-07
K051594 MCCARTNEY ACCESS TUBE Gynetech Pty. , Ltd. HEW Class II 2005-09-02
K051160 MANIPUSEAL Insitu Systems HEW Class II 2005-09-02
K042915 O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT O'My Products Incorporated NUC Class II 2005-08-31
K051413 ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 Avent America, Inc. HGX Class II 2005-08-29
K050234 REMOTE CARE E.Care Solutions, Inc. HGM Class II 2005-08-25

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