meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
33
Latest Decision
2008-11-26

Clearances · page 15 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K080446 RAPIDVIT AND RAPIDWARM CLEAVE Vitrolife Sweden AB MQL Class II 2008-11-26
K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE American Medical Systems, Inc. OTP Class III 2008-11-26
K082349 JARIT HULKA UTERINE TENACULUM FORCEPS J. Jamner Surgical Instruments, Inc. HDC Class II 2008-11-21
K082066 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER Cook Urological, Inc. HFE Class II 2008-11-07
K082369 CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR Edan Instruments, Inc. HGM Class II 2008-11-07
K081413 TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM Dailian Latex Company, Ltd. HIS Class II 2008-10-24
K081710 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE American Medical Systems OTP Class III 2008-10-15
K073522 VITRIFICATION KIT & VITRIFICATION WARMING KIT Sage In-Vitro Fertilization, Inc. MQL Class II 2008-10-10
K082802 MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B Learning Curve Brands Inc. the First Years HGX Class II 2008-10-09
K081385 URESTA PESSARY Eastmed, Inc. HHW Class II 2008-10-09
K082571 AVAULTA SUPPORT SYSTEM C.R. Bard, Inc. OTP Class III 2008-09-30
K080948 HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH Olympus Medical Systems Corporation HET Class II 2008-09-26
K081236 K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME Mcneil-Ppc, Inc. NUC Class II 2008-09-25
K081639 ICSI CUMULASE Medicult A/S MQL Class II 2008-09-19
K081115 G-MOPS G5 SERIES Vitrolife Sweden AB MQL Class II 2008-09-17
K081117 G-2 V5 Vitrolife Sweden AB MQL Class II 2008-09-16
K081114 G-1 V5 Vitrolife Sweden AB MQL Class II 2008-09-16
K082307 EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT Evenflo Company, Inc. HGX Class II 2008-09-11
K080775 MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS Tosama D.D. HEB Class II 2008-09-10
K080473 EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED Medicult A/S MQL Class II 2008-09-03
K081116 G-IVF G5 SERIES Vitrolife Sweden AB MQL Class II 2008-09-02
K080040 ORTHO ALL-FLEX DIAPHRAGM Johnson & Johnson Produtos Profissionais Ltda. HDW Class II 2008-08-25
K081048 PINNACLE PELVIC FLOOR REPAIR KIT II Boston Scientific Corp OTP Class III 2008-08-22
K081896 BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH Biogenics, Inc. MQK Class II 2008-08-20
K080395 SUNIVF DISHES <Genx> Intl., Inc. MQK Class II 2008-08-13
K080833 LOVE GUARD MALE LATEX CONDOM Tianjin Human-Care Latex Corporation HIS Class II 2008-08-07
K081070 INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM Interlace Medical, Inc. HIH Class II 2008-07-23
K072741 PRE-VA VAGINAL LUBRICANT Ingfertility, LLC PEB Class II 2008-07-16
K073581 ICI P AND S SERIES IR CAMERAS Texas Infrared LHQ Class I 2008-07-11
K080200 WATER WORKS DOUCHING DEVICE Abbott Research Group, Inc. HED Class I 2008-07-10
K081555 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED Procter & Gamble Co. HIL Class II 2008-06-27
K072169 DUREX SYNTHETIC POLYISOPRENE MALE CONDOM Ssl Americas, Inc. MOL Class II 2008-06-19
K081203 OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 Philips Medizin Systeme Boeblingen GmbH HGM Class II 2008-05-28
K072600 INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES Sunlight Medical, Inc. MQH Class II 2008-05-19
K071512 GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS ETHICON, Inc. OTP Class III 2008-05-15
K080752 CONCEIVEX LATEX-FREE SEMEN COLLECTOR Conceivex, Inc. OBB Class II 2008-05-14
K072236 DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT Ssl Americas NUC Class II 2008-05-07
K073690 INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM Interlace Medical, Inc. HIH Class II 2008-04-17
K080185 AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM American Medical Systems, Inc. OTP Class III 2008-04-10
K070587 ELEGANCE WOMAN'S LUBRICANT Julie Williams, Pa-C NUC Class II 2008-04-10
K080226 NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 Hill-Rom Manufacturing, Inc. HGM Class II 2008-04-09
K071626 DUREX PLAY SOFT & SENSUAL LUBRICANT Ssl Americas NUC Class II 2008-04-01
K080087 SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR Edan Instruments, Inc. KNG Class II 2008-03-11
K063385 DUREX PLAY MASSAGE GEL LUBRICANT Ssl Americas, Inc. NUC Class II 2008-03-10
K072421 K-Y BRAND YOURS+MINE Mcneil-Ppc, Inc. NUC Class II 2008-03-06
K070800 LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM Ansell Healthcare Products, LLC MOL Class II 2008-03-06
K070965 ALICIA MENSTRUAL CUP Alicia International Pty , Ltd. HHE Class II 2008-03-05
K072609 SINGLE STEP MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2008-02-12
K072942 MEDLINE DISPOSABLE VAGINAL SPECULUM Medline Industries, Inc. HIB Class II 2008-02-08
K072691 CERVICAL MD, MODEL C10 Sti Medical Systems HEX Class II 2008-01-31
K072381 SOFTPAP CERVICAL CELL COLLECTOR Cytocore, Inc. HHT Class II 2008-01-30
K072608 LYOPHILIZED MULTIBLAST MEDIUM KIT Irvine Scientific Sales Co., Inc. MQL Class II 2008-01-30
K072753 REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES Rg Medical USA HIF Class II 2008-01-25
K072647 GLYCERIN & PARABEN FREE ASTROGLIDE Biofilm, Inc. NUC Class II 2008-01-25
K072607 LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT Irvine Scientific Sales Co., Inc. MQL Class II 2008-01-25
K063223 MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS CooperSurgical, Inc. HDW Class II 2008-01-23
K072762 DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM Depalt, Inc. HIB Class II 2008-01-22
K073662 PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS Playtex Products, Inc. HIL Class II 2008-01-17
K070511 RICHTER MALE LATEX CONDOM Richter Rubber Technology Sbn Bhd HIS Class II 2008-01-14
K073452 MODIFICATION TO: ARAGON SURGICAL LAPCAP Aragon Surgical, Inc. HIF Class II 2008-01-11
K073221 CADENCE II Edan Instruments, Inc. HGM Class II 2007-12-28
K072976 MODEL 250CX SERIES MATERNAL/FETAL MONITOR GE Healthcare HGM Class II 2007-12-20
K072951 PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES Sofradim Production OTP Class III 2007-12-19
K070783 SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR Sopro HIF Class II 2007-12-13
K072360 K-Y BRAND INTRIGUE INTENSE WARMING SENSATION Mcneil-Ppc, Inc. NUC Class II 2007-12-12
K072376 PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS Playtex Products, Inc. HIL Class II 2007-12-12
K073182 GYN DISPOSABLES TENACULUM 356T Gyn-Disposables, Inc. HDC Class II 2007-11-28
K071127 FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. HIH Class II 2007-11-16
K072747 UNIDUS MAGNUM MALE LATEX CONDOM Unidus Corp. HIS Class II 2007-11-15
K073053 COLPO-MASTER United Products & Instruments, Inc. HEX Class II 2007-11-15
K073016 TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT Church & Dwight Co., Inc. HIS Class II 2007-11-09
K071957 PINNACLE PELVIC FLOOR REPAIR KITS Boston Scientific Corp OTP Class III 2007-11-08
K070315 LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 Lina Medical Aps KNF Class II 2007-10-30
K071313 TROJAN-ENZ BRAND Church & Dwight Co., Inc. HIS Class II 2007-10-26
K070845 SOUNMED COLOPOSCOPE COLPO-99/99PLUS Sounmed, Inc. HEX Class II 2007-10-12
K071405 PROBE HOLDER SYSTEM Intuitive Surgical, Inc. LKF Class II 2007-10-09
K071907 VCARE RETRACTOR/ELEVATOR Conmed Corporation LKF Class II 2007-10-05
K071800 PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN HGM Class II 2007-09-27
K070937 MULTIPLE BRAND MALE LATEX CONDOM Nulatex Sdn. Bhd. HIS Class II 2007-09-21
K061539 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE Clinical Innovations, LLC HFX Class II 2007-09-20
K071827 ALWAYS MENSTRUAL PADS Procter & Gamble, Inc. HHD Class I 2007-09-20
K071272 TROJAN THINTENSITY BRAND MALE LATEX CONDOM Church & Dwight Co., Inc. HIS Class II 2007-09-12
K070623 PHARMAPAC LUBRICATING JELLY Pharmapac, LLC NUC Class II 2007-08-31
K070135 VITRIFREEZE MEDIUM; VITRITHAW MEDIUM Fertipro NV MQL Class II 2007-08-16
K070877 ENDOCERVICAL ELECTRODE # 2 Modern Medical Equipment Mfg., Ltd. HGI Class II 2007-07-27
K070435 DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 Whittlestone, Inc. HGX Class II 2007-07-17
K070689 LG SPERM FREEZING Genx Intl., Inc. MQL Class II 2007-07-03
K070651 ARAGON SURGICAL LAPCAP Aragon Surgical, Inc. HIF Class II 2007-05-30
K063611 SALINE/ CONTRAST MEDIA INFUSION CATHETER Utah Medical Products, Inc. LKF Class II 2007-05-23
K063367 45L CORE INSUFFLATOR, MODEL F114 W.O.M. World of Medicine AG HIF Class II 2007-05-23
K070047 NUNC IVF DISHES AND NUNC IVF 4-WELL DISH Nunc A/S MQK Class II 2007-05-18
K062563 FEMTEN CERVICAL TENACULUM Fem Suite, LLC HDC Class II 2007-05-18
K070964 KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM Welch Allyn, Inc. HIB Class II 2007-05-18
K070830 MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) Karex Industries Sdn. Bhd. HIS Class II 2007-05-08
K063636 ZILOS-TK Hamilton Thorne Biosciences MRX Class II 2007-04-24
K070745 MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS Playtex Products, Inc. HIL Class II 2007-04-13
K062682 CVS PERSONAL LUBRICANT AND MOISTURIZER Lake Consumer Products, Inc. NUC Class II 2007-04-04
K063401 BANANA RIBBED Medtech Products , Ltd. HIS Class II 2007-03-26
K070545 K-Y BRAND WARMING LIQUID Personal Products Co. NUC Class II 2007-03-23
K062433 DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM Diamics, Inc. HHT Class II 2007-03-16

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