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Obstetrics/Gynecology

4,608 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (K092984)Panpac Medical Corporation2010-04-07
LIFEGLOBAL PROTEIN SUPPLEMENT (K092578)Genx Intl., Inc.2010-04-05
INTRAUTERINE INSEMINATION (IUI) CATHETER (K092579)Fertiligent, Ltd.2010-04-02
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K100559)Interlace Medical, Inc.2010-03-30
GYNCARE MORCELLEX TISSUE MORCELLATOR (K100280)ETHICON, Inc.2010-03-24
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP (K100385)Luv N' Care, Ltd.2010-03-24
VCARE DX (K093556)Conmed Corporation2010-03-12
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 (K092980)Panpac Medical Corporation2010-03-11
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (K093508)Womancare Global2010-03-04
VIT KIT - FREEZE AND THAW (K093273)Irvine Scientific Sales Co., Inc.2010-03-03
LUBREASE FEMALE LUBRICANT (K091298)Curves Limited2010-02-24
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 (K092028)Philips Medizin Systeme Boeblingen GmbH2010-02-17
NON-STERILE DISPOSABLE VAGINAL SPECULUM (K092870)Kunshan Deyi Plastic Co., Ltd.2010-02-16
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC (K092421)Gimmi GmbH2010-02-12
TRUST DAM (K091769)Line One Laboratories, Inc.2010-02-05
LAP LOOP (K092897)Medsys, S.A.2010-02-01
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (K092827)Dimeda Instrumente GmbH2010-01-08
RAPID-I (K090832)Vitrolife Sweden AB2009-12-23
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS (K091749)Kimberly-Clark Corp.2009-12-23
ONTEX TAMPON (UNSCENTED) (K090819)Ontex International NV2009-12-23
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK (K091838)Obp Medical2009-12-04
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (K092840)Instrumed International, Inc.2009-12-03
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754)Lune Group , Ltd.2009-11-13
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 (K092997)Edan Instruments, Inc.2009-11-10
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K091100)Interlace Medical, Inc.2009-10-23
DEBP (K092783)Enko , Ltd.2009-10-22
THAI NIPPON MALE LATEX CONDOM (K081265)Thai Nippon Rubber Industry Co., Ltd.2009-10-16
SIMPLYGO HANDS FREE BREAST PUMP (K092770)Evenflo Company, Inc.2009-10-09
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 (K092278)Gyrus Acmi, Inc.2009-09-29
ALPHA DUO LAP INSUFFLATOR (K090652)Hippokratec GmbH2009-09-25
NUNC IVF CENTERWELL AND ICSI DISHES (K090429)Thermo Fisher Scientific (Nalge Nunc Intl)2009-09-18
M. DIOR BRAND (K083817)Suzhou Colour-Way Enterprise Development Co., Ltd.2009-09-16
OVA1 TEST (DEN090004)Vermillion2009-09-11
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (K091937)Obp Corporation2009-09-09
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (K082939)Cook Urological, Inc.2009-09-03
INSUFLOW DEWHEART (K091366)Lexion Medical, LLC2009-09-03
INSUFLOW (K090456)Lexion Medical, LLC2009-08-26
SATURN ACTIVE LASER SYSTEM (K083208)Research Instruments , Ltd.2009-08-25
CERNER FETALINK (VERSION 1.0) (K091251)Cerner Corp.2009-08-25
MYOSURE ROD LENS HYSTEROSCOPE (K091465)Interlace Medical, Inc.2009-08-21
PHARMAPAC PERSONAL LUBRICANT (K091554)Pharmapac, LLC2009-08-07
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON (K092054)Tosama D.D.2009-07-29
EZ HSG CATHETER.FOAMSEAL CATHETER (K083594)Obg Products2009-07-21
SONICAID FM820 AND FM830 ENCORE (K090285)Huntleigh Healthcare , Ltd.2009-07-15
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (K080365)NOUVAG AG2009-06-29
FEMVUE(TM) CATHETER SYSTEM (K083690)Femasys, Inc.2009-06-23
EXTT-101 (K082436)Apimeds, Inc.2009-05-29
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS (K090071)Rostam , Ltd.2009-05-28
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM (K082529)Alatech Healthcare, LLC2009-05-01
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS (K082363)William A. Cook Australia Pty. , Ltd.2009-04-29
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS (K091084)Cotton High Tech S.L.2009-04-29
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (K083509)Genx Intl., Inc.2009-04-24
WALGREEN'S PERSONAL LUBRICATING JELLY (K080978)Topco Sales2009-04-23
PAPCONE (K083012)Otto Bock Pur Life Science GmbH2009-04-09
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
OKAMOTO ULTRA THIN (K090259)Okamoto USA, Inc.2009-03-31
ASCEND (K083722)Caldera Medical, Inc.2009-03-31
LIFEDOP MODEL, L350R (K090499)Summit Doppler Systems, Inc.2009-03-31
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 (K080852)KARL STORZ Endoscopy-America, Inc.2009-03-30
CONTEC POCKET FETAL DOPPLER (K082480)Contec Medical System Co., Ltd.2009-02-25
COTTONS 100% NATURAL COTTON TAMPONS (K080733)Cottons Pty, Ltd.2009-02-18
AIRSTRIP OB (K090269)Airstrip Technologies, LP2009-02-13
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP (K081463)Medel S.P.A.2009-02-06
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN (K082727)Vitrolife Sweden AB2009-02-06
MODEL PC-860 FETAL DOPPLER (K082055)Shenzhen Creative Industry Co., Ltd.2009-02-06
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED (K081886)Karex Industries Sdn. Bhd.2009-02-06
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON (K090098)Maxim Hygiene Products, Inc.2009-01-30
AIRSTRIP OB (K090061)Airstrip Technologies, LP2009-01-23
ENDEARE BREAST PUMP (K081932)Hygeia Medical, Inc.2009-01-22
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K083839)C.R. Bard, Inc.2009-01-15
MODIFICATION TO URESTA PESSARY (K083769)Eastmed, Inc.2009-01-14
NEO-VAGINA SURGERY SET AND ACCESSORIES (K071754)KARL STORZ Endoscopy-America, Inc.2009-01-07
ENDOSCOPIC CO2 REGULATION UNIT UCR (K081173)Olympus Medical Systems Corporation2008-12-23
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677)American Medical Systems, Inc.2008-12-23
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 (K080172)Medicult A/S2008-12-18
STRYKER VIDEOSCOPE (K082451)Stryker Endoscopy2008-12-16
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (K081522)Bio Nuclear Diagnostics, Inc.2008-12-05
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM (K082387)American Medical Systems2008-12-04
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE (K082730)American Medical Systems, Inc.2008-11-26
RAPIDVIT AND RAPIDWARM CLEAVE (K080446)Vitrolife Sweden AB2008-11-26
FETAL & MATERNAL MONITOR, MODEL F6, F9 (K082602)Edan Instruments, Inc.2008-11-26
JARIT HULKA UTERINE TENACULUM FORCEPS (K082349)J. Jamner Surgical Instruments, Inc.2008-11-21
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR (K082369)Edan Instruments, Inc.2008-11-07
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (K082066)Cook Urological, Inc.2008-11-07
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM (K081413)Dailian Latex Company, Ltd.2008-10-24
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE (K081710)American Medical Systems2008-10-15
VITRIFICATION KIT & VITRIFICATION WARMING KIT (K073522)Sage In-Vitro Fertilization, Inc.2008-10-10
URESTA PESSARY (K081385)Eastmed, Inc.2008-10-09
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B (K082802)Learning Curve Brands Inc. the First Years2008-10-09
AVAULTA SUPPORT SYSTEM (K082571)C.R. Bard, Inc.2008-09-30
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH (K080948)Olympus Medical Systems Corporation2008-09-26
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME (K081236)Mcneil-Ppc, Inc.2008-09-25
ICSI CUMULASE (K081639)Medicult A/S2008-09-19
G-MOPS G5 SERIES (K081115)Vitrolife Sweden AB2008-09-17
G-2 V5 (K081117)Vitrolife Sweden AB2008-09-16
G-1 V5 (K081114)Vitrolife Sweden AB2008-09-16
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT (K082307)Evenflo Company, Inc.2008-09-11
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