Atlas FDA

Obstetrics/Gynecology

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

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RecordFirmDate
Endosee System (K190639)CooperSurgical, Inc.2019-05-15
Hysteroscope System (K181545)Shanghai AnQing Medical Instrument Co., Ltd.2019-05-10
Wallace Dual Lumen Oocyte Recovery System (K182959)CooperSurgical, Inc.2019-05-10
Unscented Menstrual Tampon (K190218)Qingdao Youjia Hygiene Technology Co., Ltd.2019-05-09
Gynescope System (K190187)Illumigyn , Ltd.2019-05-08
JO Actively Trying Personal Lubricant (K182585)United Consortium2019-04-26
exCellerator Cervical Collection Device (K182049)Excell Company, LLC2019-04-25
Smile Makers Personal Lubricant (K182100)Lfbeauty (Thailand) Limited2019-04-25
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K190113)Corinth Medtech, Inc.2019-04-24
JO H2O Jelly Original Personal Lubricant (K183584)United Consortium2019-04-17
KY Banksy Aloe (K183302)Rb Health (Us), LLC2019-04-16
One Touch (K181844)Thai Nippon Rubber Industry Public Company, Ltd.2019-04-15
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (K181770)Cook Incorporated2019-03-29
AirSeal (K190303)Conmed Corporation2019-03-28
InTouch Thermal Camera (K181716)Intouch Technologies, Inc., D.B.A. Intouch Health2019-03-25
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT (K182813)Cotton High Tech S.L.2019-03-15
Electric Breast Pump (K182413)Guangdong Horigen Mother & Baby Products Co., Ltd.2019-03-07
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (K183384)United Consortium2019-03-04
Fetal Doppler, Model FD88 (K182710)Shenzzhen Luckcome Technology Inc., Ltd.2019-03-01
Endosee System (K183020)CooperSurgical, Inc.2019-01-31
Revive Reusable Bladder Support (K183468)Rinovum Subsidiary 2, LLC2019-01-25
Rapid-i™ Kit (K181461)Vitrolife Sweden AB2019-01-04
Polygon Resection Device (K182675)Polygon Medical, Inc.2019-01-04
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control (K181127)Interscope, Inc.2019-01-03
Creme de La Femme Feminine Lubricant (K180014)Cewal, Inc. Dba Premiere Enterprises2018-12-21
Natureplex Warm Touch Warming Jelly (K180828)Natureplex, LLC2018-12-20
Fetal Doppler (K182190)Shenzhen AOJ Medical Technology Co., Ltd.2018-12-19
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (K182006)Hologic, Inc.2018-12-06
Synthetic Polyisoprene Lubricated Male Condom - 5 senses (K182438)Sxwell USA, LLC2018-12-06
Spectra S3 Plus (K181784)Uzinmedicare Co.2018-11-30
Biop Digital Colposcope (K182764)Biop Medical , Ltd.2018-11-27
Wet Organics Personal Lubricant (K182027)Trigg Laboratories Dba Wet International2018-11-21
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant (K182105)United Consortium2018-11-14
Cryotop®US-flash and Cryotop®US-scoop (K181469)Kitazato Corporation2018-11-09
Interlude 100% Cotton Tampon (K181911)Albaad Fem2018-11-02
Endomat Select (K180735)Karl Storz SE & CO. KG2018-10-31
Panpac Flexi Shelf Pessary (K173351)Panpac Medical Corporation2018-10-31
Margolin HSG Cannula, Goldstein Sonohysterography Catheter (K180300)Cook Incorporated2018-10-26
Cook Silicone Balloon HSG Catheter (K180291)Cook Incorporated2018-10-26
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter (K180302)Cook Incorporated2018-10-24
Cumulus Remover (K182002)Kitazato Corporation2018-10-23
Pump In Style Advanced, Advanced Personal Double Breastpump (K181937)Medela, LLC2018-10-16
Elvie Pump (K181863)Chiaro Technology Limited2018-10-10
Acessa ProVu System (K181124)Acessa Health, Inc.2018-09-28
Pocket Colposcope System (K181034)Hadleigh Health Technologies, LLC2018-09-21
The Sex Gel (K181078)Necessaire, Inc.2018-09-10
IntelliSpace Perinatal Rev.K.00 (K173941)Philips Medizin Systeme Boeblingen GmbH2018-09-10
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042)Edan Instruments, Inc.2018-08-30
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set (K180073)Shenzhen Vitavitro Bio-Tech Co., Ltd.2018-08-29
TruClear Elite Hysteroscope (K180496)Covidien2018-08-29
JO Classic Hybrid Personal Lubricant (K181408)United Consortium2018-08-27
MyoSure XL Tissue Removal Device for Fluent (K181974)Hologic, Inc.2018-08-23
re.t.a Reuseable Tampon Applicator (K180850)Thinx, Inc.2018-08-20
Sonata Sonography-Guided Transcervical Fibroid Ablation System (K173703)Gynesonics, Inc.2018-08-15
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (K181151)ETHICON, Inc.2018-08-10
Natural Cycles (DEN170052)Natural Cycles Nordic AB2018-08-10
MINUET LCD, MINUET LCD eco (K180075)Unimom.Co2018-08-06
Fluent Fluid Management System (K180825)Hologic, Inc.2018-08-03
TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (K180764)Church & Dwight Co., Inc.2018-08-01
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole (K180752)Corinth Medtech, Inc.2018-07-25
Ultrasonic Doppler (Model YM-2T8) (K180419)Shenzhen Imdk Medical Technology Co., Ltd.2018-07-19
Modified Novy Cornual Cannulation Set (K180552)Cook Incorporated2018-07-12
Personal Lubricating Jelly (K180923)Perrigo New York, Inc.2018-07-09
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (K173019)ETHICON, Inc.2018-07-06
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide (K173162)ETHICON, Inc.2018-06-28
Uterine Manipulator (K172846)Beijing Hangtian Kadi Technology R&D Institute2018-06-26
GCE704 Breast Pump (K172842)Globalcare2018-06-18
Interlude and private label Unscented 3-piece compact applicator tampon (K173225)Albaad Fem2018-06-15
GRI-Alleset Veress Needle (K172835)Gri Medical and Electronic Technology Co., Ltd.2018-06-11
HSW Resection Instruments (K173070)Henke-Sass, Wolf GmbH2018-06-08
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (K180188)Genea Biomedx Pty, Ltd.2018-06-07
Coconut Infused Hybrid Personal Lubricant (K180712)United Consortium2018-06-06
SD1 Ultrasonic Pocket Doppler (K172780)Edan Instruments, Inc.2018-06-06
BioNude Lubricant (K180136)Good Clean Love, Inc.2018-06-01
Playtex Stella Tampons (K180167)Playtex Manufacturing, Inc.2018-05-30
Towako Transmyometrial Embryo Transfer Set (K173431)William A. Cook Australia Pty. , Ltd.2018-05-18
EmbryoScope+ (K173264)Vitrolife A/S2018-05-11
MyoSure MANUAL Tissue Removal Device (K173901)Hologic, Inc.2018-05-08
Fetzer Medical Gynecological Forceps (K172661)Fetzer Medical GmbH & Co. KG2018-05-08
VitriGuard (K180740)Origio A/S2018-05-04
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left (K172614)Caldera Medical, Inc.2018-05-04
AlertWatch:OB (K173715)Alertwatch, Inc.2018-04-23
Geri Embryo Incubator and Geri Dish (K180304)Genea Biomedx Pty, Ltd.2018-04-20
JO H2O Flavored Personal Lubricants (K180219)United Consortium2018-04-20
SuperSlyde Personal Lubricant (K172306)Icm Pharma Pte, Ltd.2018-04-19
GDT-1000 System (K180096)Acuvu, Inc.2018-04-16
Pivet and Soft-Pass Embryo Transfer Catheter Sets (K173103)Cook Incorporated2018-04-13
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (K173686)Cook Incorporated2018-04-11
Hysteroscopy System (K172151)Chongquin Jinshan Science & Technology (Group) Co., Ltd.2018-04-09
Silicone Personal Lubricant, ALL-IN-ONE (K180083)United Consortium2018-04-09
leva Pelvic Floor Trainer (K180637)Renovia, Inc.2018-04-04
The Pump by Babyation (K173699)Babyation, LLC2018-04-04
GYN-Pump PH304 (K173489)W.O.M. World of Medicine GmbH2018-03-28
SurgiQuest AIRSEAL iFS System (K172516)Conmed Corporation2018-03-16
Advincula Delineator Uterine Manipulator (K180429)CooperSurgical, Inc.2018-03-14
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (K180104)Church & Dwight Co., Inc.2018-03-14
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (K173075)Dxnow, Inc.2018-03-08
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (K173731)CooperSurgical, Inc.2018-03-02
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) (K173624)Origio A/S2018-03-02
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip (K171604)Cook Incorporated2018-02-15
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