Atlas FDA

Obstetrics/Gynecology

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

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RecordFirmDate
TEMED Gas Diffuser (K173545)Temed2018-02-14
Digitex Delivery Device (K173527)Coloplast A/S2018-02-12
Meridian Vaginal Positioning System (VPS) (K173501)Coloplast2018-02-09
Tosama Biobased Applicator Tube Menstrual Tampon (K172504)Tosama, D.O.O.2018-02-09
iVitri Straw (K172751)Reprobitech Corp.2018-02-09
Flip Lube (K171516)Imquest Biosciences, Inc.2018-02-05
Aquilex Fluid Control System AQL-100S (K172040)W.O.M. World of Medicine GmbH2018-02-05
Flex Robotic System and Flex Transabdominal Drive (K172796)Medrobotics Corporation2018-01-18
One Touch Condom with Benzocaine (K171213)Thai Nippon Rubber Industry Public Company Limited.2018-01-12
Single Lumen Ovum Aspiration Needles (K171625)Willian A. Cook Australia Pty, Ltd.2018-01-12
K-Y Silicone (K173504)Reckitt Benckiser, LLC2018-01-12
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter (K172051)Cook Incorporated2018-01-10
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module (K171113)Lina Medical Aps2018-01-04
remOVE System (DEN160014)Ovesco Endoscopy AG2017-12-22
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters (K172321)Cook Incorporated2017-12-21
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (K172565)Boston Scientific Corporation2017-12-20
Electric Breast Pump (K172989)Joytech Healthcare Co. , Ltd.2017-12-20
LifeStyles® SKYN® Intimate Moments Personal Lubricant (K172473)Sxwell USA, LLC2017-12-15
Double Lumen Ovum Aspiration Needles (K171611)William A. Cook Australia Pty. , Ltd.2017-12-15
Vitrification Kit and Thawing Kit (K171748)Kitazato Corporation2017-12-14
Med-Hot Thermal Imaging Systems (K171928)Med-Hot Thermal Imaging, Inc.2017-12-08
wettrust D2care (K170797)Wettrust Korea Co., Ltd.2017-12-06
One Mum Pumpset (K172067)Ardo Medical AG2017-11-29
LAP-iX Suction Irrigation (K173111)Sejong Medical Co., Ltd.2017-11-28
Climax Personal Lubricant (K171044)Wsm Investment, LLC, Dba Topco Sales2017-11-21
Follicle Aspiration Set, Reduced Single Lumen (K172050)Vitrolife Sweden AB2017-11-21
Geri Embryo Incubator and Geri Dish (K171736)Genea Biomedx Pty, Ltd.2017-11-15
AP 50/30 Insufflator with Insuflow Port (K170799)Lexion Medical, LLC2017-11-14
Capio SLIM Suture Capturing Device (K172060)Boston Scientific Corporation2017-11-03
JO Gelato Flavored Personal Lubricants (K172447)United Consortium2017-10-31
Freemie Independence, Freemie Liberty (K172772)Dao Health2017-10-13
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (K172197)Origio A/S2017-10-13
JUD custom fit condom (K172414)Global Mailer Partners, LLC2017-10-12
U by Kotex Click Unscented Menstrual Tampons (K172118)Kimberly-Clark Corporation2017-10-11
Yooeehouse Breast Pump (K163183)Nantong Poly Technology Co., Ltd.2017-10-02
Berkeley VC-10 Vacuum Curettage System (K171440)Gyrus Acmi2017-09-29
Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (K170498)Genea Biomedx Pty, Ltd.2017-09-28
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry (K163674)Neo Cosmetique2017-09-22
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K172566)Hologic, Inc.2017-09-20
FuckWater (K171730)Non-Friction Products, Inc.2017-09-07
Central Monitoring System (K171178)Edan Instruments, Inc.2017-09-06
FluidSmart (K172048)Thermedx, LLC2017-09-05
Arctic Sperm Cryopreservation Medium (K171224)Irvine Scientific Sales Co., Inc.2017-08-31
Astroglide O Oil Personal Lubricant & Massage Oil (K171985)Biofilm, Inc.2017-08-30
Feminine Personal Trainer (FPT) (K171896)Ralston Group2017-08-29
Moxxly Flow Collection System (K170722)Moxxly, Inc.2017-08-28
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring (K171865)Farus, LLC2017-08-24
Skyn Original Polyisoprene Lubricated Male Condom - Flavored (K171172)Ansell Healthcare Products, LLC2017-08-02
Trojan Supra Lubricated Polyurethane Male Condom (K171639)Church & Dwight Co., Inc.2017-08-01
Youha electric breast pump (K163136)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2017-07-31
FETAL PILLOW (DEN150053)Safe Obstetric Systems, Ltd.2017-07-27
External Moisturizing Gel (K171855)Combe Incorporated2017-07-21
JO Agapé Personal Lubricant (K171021)United Consortium2017-07-18
Soules Intrauterine Insemination Catheter (K163318)Cook Incorporated2017-07-14
Kitazato ET Catheters (K162878)Kitazato Corporation2017-07-13
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (K170660)CooperSurgical, Inc.2017-07-13
Kitazato OPU Needles (K162881)Kitazato Corporation2017-07-11
iVitri EZ (K162640)Reprobitech Corp.2017-06-30
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit (K162582)Fisher & Paykel Healthcare2017-06-23
Follicle Aspiration Set (K161970)Vitrolife Sweden AB2017-06-14
COOK Vacuum Pump (K160753)William A. Cook Australia Pty. , Ltd.2017-06-13
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer (K162569)Biotech Lubricants, Ltd.2017-06-09
Vibrance Pelvic Trainer (K162689)Bioinfinity (M) Sdn. Bhd.2017-06-08
Continuous Single Culture -NX (CSCM-NX) (K170681)Irvine Scientific Sales Co., Inc.2017-06-08
Continuous Single Culture-NX Complete (CSCM-NXC) (K170602)Irvine Scientific Sales Co., Inc.2017-06-07
Gems Vitrification Set, Gems Warming Set (K162409)Genea Biomedx Pty, Ltd.2017-05-24
Tao Brush I.U.M.C. Endometrial Sampler (K170603)Cook Incorporated2017-05-24
LT-300 SD Digital Video Colposcope (K170446)Lutech Industries, Inc.2017-05-21
LaparoLight Veress Needle (K171139)Buffalo Filter, LLC2017-05-18
PNEUMOCLEAR (K170784)W.O.M. World of Medicine GmbH2017-05-15
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (K161261)Genea Biomedx Pty, Ltd.2017-05-12
Kitazato IUI Catheter (K162667)Kitazato Corporation2017-05-11
Restore Moisturizing Vaginal Lubricant (K162207)Good Clean Love2017-05-04
BabyDance Fertility Lubricant (K162319)Fairhaven Health, LLC2017-04-28
EndoRotor (K170120)Interscope, Inc.2017-04-18
SAGE Vitrification Kit and SAGE Vitrification Warming Kit (K170560)CooperSurgical, Inc.2017-04-04
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622)Cook Incorporated2017-03-31
LUVENA VAGINAL MOISTURIZER & LUBRICANT (K162235)Laclede, Inc.2017-03-24
LAP-Pump PP110 (K163320)W.O.M. World of Medicine GmbH2017-03-21
Spectra 9Plus (K162415)Uzinmedicare Company2017-03-15
Transem and EchoGen Embryo Transfer Catheters (K161547)Origio A/S2017-03-09
CIMLRE F1 and CIMILRE S3 (K162870)Cimilre Co., Ltd.2017-03-07
Male Latex Condoms (K162919)Zhejiang Xiangban Latex Products Co., Ltd.2017-03-07
Ontex and other proprietary names (K162746)Ontex Bvba2017-03-03
ENDOFLATOR 40, ENDOFLATOR 50 (K161554)KARL STORZ Endoscopy-America, Inc.2017-03-02
Sydney IVF Culture Oil (K170257)William A. Cook Australia Pty. , Ltd.2017-02-24
VitriGuard (K162833)Origio A/S2017-02-16
Astroglide Diamond Silicone Gel Personal Lubricant (K163395)Biofilm, Inc.2017-02-10
PUREtrace™ (K153262)Nemo Healthcare BV2017-02-07
Unicare System, Unicare Manipulator (K163214)Clearpath Surgical, Inc.2017-02-07
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (K161275)Research Instruments Limited2017-01-23
Lifestyles Zero Lubricated Latex Male Condom (K163107)Ansell Healthcare Products, LLC2017-01-23
LELO RESPECT HEX Natural Rubber Latex Condom (K162511)Lelo, Inc.2017-01-13
PANPAC DISPOSABLE VACUUM CURETTES (K161106)Panpac Medical Corporation2017-01-13
Kolplast Cervical Sample Collection Kit (K153128)Kolplast CI SA2017-01-13
Meridian M110 Fetal Monitoring System (K161902)Mindchild Medical2017-01-12
Love Alchemy's Love Lotion (K151857)Love Alchemy, LLC2017-01-09
Sentinel BreastScan II System (K162767)First Sense Medical, LLC2017-01-09
CrossBay IVF Embryo Transfer Catheter Set (K162064)Crossbay Medical, Inc.2017-01-05
Hem-Avert Perianal Stabilizer (DEN160005)Stetrix, Inc.2016-12-19
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