meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
32
Latest Decision
2010-06-16

Clearances · page 14 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100929 UNIMOM ALLEGRO Blue Egg CO HGX Class II 2010-06-16
K092107 VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 Nidacon International AB MQL Class II 2010-06-15
K100885 FETAL MONITOR MODEL: BT-200T Bistos Co., Ltd. HGM Class II 2010-06-07
K092983 PANPAC HSG CATHETER SET Panpac Medical Corporation LKF Class II 2010-06-07
K092667 GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT Genx Intl., Inc. MQL Class II 2010-06-03
K091281 TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA Procter & Gamble Co. HEB Class II 2010-06-01
K100435 AMEDA PLATINUM BREAST PUMP Evenflo Company, Inc. HGX Class II 2010-05-28
K100626 DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 Shenzhen Biocare Electronics Co., Ltd. KNG Class II 2010-05-21
K093218 FEMEYE TWO Fem Suite, LLC HIH Class II 2010-05-18
K092586 MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU Innolatex (Thailand) Limited HIS Class II 2010-05-12
K094039 HYALO GYN Fidia Farmaceutici S.P.A. NUC Class II 2010-05-07
K092554 BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES Sunlight Medical, Inc. MQH Class II 2010-04-30
K092969 H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F Sterling Medical, Inc. LKF Class II 2010-04-30
K091958 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM Glenveigh Surgical, LLC OQY Class II 2010-04-30
K090510 DOPPLER FETAL HEARTBEAT RATE DETECTOR Shenzhen Bestman Instrument Co., Ltd. KNG Class II 2010-04-29
K100517 INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX Instrumed International, Inc. HDA Class II 2010-04-29
K093904 GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER Glenveigh Surgical, LLC KNA Class II 2010-04-14
K100662 FEMVUE CORNUAL BALLOON CATHETER Femasys, Inc. LKF Class II 2010-04-07
K092984 PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 Panpac Medical Corporation LKF Class II 2010-04-07
K092578 LIFEGLOBAL PROTEIN SUPPLEMENT Genx Intl., Inc. MQL Class II 2010-04-05
K092579 INTRAUTERINE INSEMINATION (IUI) CATHETER Fertiligent, Ltd. MQF Class II 2010-04-02
K100559 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM Interlace Medical, Inc. HIH Class II 2010-03-30
K100385 NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP Luv N' Care, Ltd. HGX Class II 2010-03-24
K100280 GYNCARE MORCELLEX TISSUE MORCELLATOR ETHICON, Inc. HET Class II 2010-03-24
K093556 VCARE DX Conmed Corporation LKF Class II 2010-03-12
K092980 PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 Panpac Medical Corporation LKF Class II 2010-03-11
K093508 RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) Womancare Global HGH Class II 2010-03-04
K093273 VIT KIT - FREEZE AND THAW Irvine Scientific Sales Co., Inc. MQL Class II 2010-03-03
K091298 LUBREASE FEMALE LUBRICANT Curves Limited NUC Class II 2010-02-24
K092028 PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 Philips Medizin Systeme Boeblingen GmbH HGM Class II 2010-02-17
K092870 NON-STERILE DISPOSABLE VAGINAL SPECULUM Kunshan Deyi Plastic Co., Ltd. HIB Class II 2010-02-16
K092421 ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC Gimmi GmbH HIH Class II 2010-02-12
K091769 TRUST DAM Line One Laboratories, Inc. MSC Class II 2010-02-05
K092897 LAP LOOP Medsys, S.A. KNF Class II 2010-02-01
K092827 DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX Dimeda Instrumente GmbH HDA Class II 2010-01-08
K090832 RAPID-I Vitrolife Sweden AB MQK Class II 2009-12-23
K091749 U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS Kimberly-Clark Corp. HEB Class II 2009-12-23
K090819 ONTEX TAMPON (UNSCENTED) Ontex International NV HEB Class II 2009-12-23
K091838 OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK Obp Medical HIH Class II 2009-12-04
K092840 INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL Instrumed International, Inc. HCZ Class II 2009-12-03
K091754 LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 Lune Group , Ltd. HHE Class II 2009-11-13
K092997 ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 Edan Instruments, Inc. KNG Class II 2009-11-10
K091100 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM Interlace Medical, Inc. HIH Class II 2009-10-23
K092783 DEBP Enko , Ltd. HGX Class II 2009-10-22
K081265 THAI NIPPON MALE LATEX CONDOM Thai Nippon Rubber Industry Co., Ltd. HIS Class II 2009-10-16
K092770 SIMPLYGO HANDS FREE BREAST PUMP Evenflo Company, Inc. HGX Class II 2009-10-09
K092278 GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 Gyrus Acmi, Inc. HIH Class II 2009-09-29
K090652 ALPHA DUO LAP INSUFFLATOR Hippokratec GmbH HIF Class II 2009-09-25
K090429 NUNC IVF CENTERWELL AND ICSI DISHES Thermo Fisher Scientific (Nalge Nunc Intl) MQK Class II 2009-09-18
K083817 M. DIOR BRAND Suzhou Colour-Way Enterprise Development Co., Ltd. HIS Class II 2009-09-16
DEN090004 OVA1 TEST Vermillion ONX Class II 2009-09-11
K091937 OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM Obp Corporation HIB Class II 2009-09-09
K082939 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 Cook Urological, Inc. KNA Class II 2009-09-03
K091366 INSUFLOW DEWHEART Lexion Medical, LLC HIF Class II 2009-09-03
K090456 INSUFLOW Lexion Medical, LLC HIF Class II 2009-08-26
K083208 SATURN ACTIVE LASER SYSTEM Research Instruments , Ltd. MRX Class II 2009-08-25
K091251 CERNER FETALINK (VERSION 1.0) Cerner Corp. HGM Class II 2009-08-25
K091465 MYOSURE ROD LENS HYSTEROSCOPE Interlace Medical, Inc. HIH Class II 2009-08-21
K091554 PHARMAPAC PERSONAL LUBRICANT Pharmapac, LLC NUC Class II 2009-08-07
K092207 RESTORELLE POLYPROPYLENE MESH Mpathy Medical Devices, Inc. OTP Class III 2009-08-04
K092054 MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON Tosama D.D. HEB Class II 2009-07-29
K083594 EZ HSG CATHETER.FOAMSEAL CATHETER Obg Products LKF Class II 2009-07-21
K090285 SONICAID FM820 AND FM830 ENCORE Huntleigh Healthcare , Ltd. HGM Class II 2009-07-15
K080365 MORCE POWER PLUS AND VARIOCARVE MORCELLATOR NOUVAG AG HET Class II 2009-06-29
K083690 FEMVUE(TM) CATHETER SYSTEM Femasys, Inc. LKF Class II 2009-06-23
K082436 EXTT-101 Apimeds, Inc. HIR Class II 2009-05-29
K090071 ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HEB Class II 2009-05-28
K091131 PELVIC FLOOR REPAIR SYSTEM Boston Scientific OTP Class III 2009-05-08
K083499 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS Coloplast A/S OTP Class III 2009-05-08
K082529 ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM Alatech Healthcare, LLC HIS Class II 2009-05-01
K091084 MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS Cotton High Tech S.L. HEB Class II 2009-04-29
K082363 COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS William A. Cook Australia Pty. , Ltd. MQL Class II 2009-04-29
K083509 LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA Genx Intl., Inc. MQL Class II 2009-04-24
K080978 WALGREEN'S PERSONAL LUBRICATING JELLY Topco Sales NUC Class II 2009-04-23
K083012 PAPCONE Otto Bock Pur Life Science GmbH HHT Class II 2009-04-09
K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP American Medical Systems, Inc. OTP Class III 2009-04-02
K090259 OKAMOTO ULTRA THIN Okamoto USA, Inc. HIS Class II 2009-03-31
K083722 ASCEND Caldera Medical, Inc. OTP Class III 2009-03-31
K090499 LIFEDOP MODEL, L350R Summit Doppler Systems, Inc. MAA Class II 2009-03-31
K080852 KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 KARL STORZ Endoscopy-America, Inc. HIF Class II 2009-03-30
K082480 CONTEC POCKET FETAL DOPPLER Contec Medical System Co., Ltd. KNG Class II 2009-02-25
K080733 COTTONS 100% NATURAL COTTON TAMPONS Cottons Pty, Ltd. HEB Class II 2009-02-18
K090269 AIRSTRIP OB Airstrip Technologies, LP HGM Class II 2009-02-13
K082055 MODEL PC-860 FETAL DOPPLER Shenzhen Creative Industry Co., Ltd. KNG Class II 2009-02-06
K081463 MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP Medel S.P.A. HGX Class II 2009-02-06
K081886 KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED Karex Industries Sdn. Bhd. HIS Class II 2009-02-06
K082727 FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN Vitrolife Sweden AB MQE Class II 2009-02-06
K090098 MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON Maxim Hygiene Products, Inc. HEB Class II 2009-01-30
K090061 AIRSTRIP OB Airstrip Technologies, LP HGM Class II 2009-01-23
K081932 ENDEARE BREAST PUMP Hygeia Medical, Inc. HGX Class II 2009-01-22
K083839 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. Bard, Inc. OTP Class III 2009-01-15
K083769 MODIFICATION TO URESTA PESSARY Eastmed, Inc. HHW Class II 2009-01-14
K071754 NEO-VAGINA SURGERY SET AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. HDX Class II 2009-01-07
K081173 ENDOSCOPIC CO2 REGULATION UNIT UCR Olympus Medical Systems Corporation HET Class II 2008-12-23
K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE American Medical Systems, Inc. OTP Class III 2008-12-23
K080172 BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 Medicult A/S MQL Class II 2008-12-18
K082451 STRYKER VIDEOSCOPE Stryker Endoscopy HET Class II 2008-12-16
K081522 BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY Bio Nuclear Diagnostics, Inc. HHT Class II 2008-12-05
K082387 APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM American Medical Systems OTP Class III 2008-12-04
K082602 FETAL & MATERNAL MONITOR, MODEL F6, F9 Edan Instruments, Inc. HGM Class II 2008-11-26

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