Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Obstetrics & Gynecology ×
4,525 results
769–792 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Jun 30, 2017
iVitri EZ
K162640 · MQK
Reprobitech Corp.
Obstetrics & Gynecology · 281d
Cleared Jun 23, 2017
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
K162582 · HIF
Fisher & Paykel Healthcare
Obstetrics & Gynecology · 281d
Cleared Jun 14, 2017
Follicle Aspiration Set
K161970 · MQE
Vitrolife Sweden AB
Obstetrics & Gynecology · 331d
Cleared Jun 13, 2017
COOK Vacuum Pump
K160753 · MQG
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 452d
Cleared Jun 09, 2017
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES...
K162569 · NUC
Biotech Lubricants, Ltd.
Obstetrics & Gynecology · 267d
Cleared Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
K170681 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Jun 07, 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 98d
Cleared May 24, 2017
Gems Vitrification Set, Gems Warming Set
K162409 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 268d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · HFE
Cook Incorporated
Obstetrics & Gynecology · 84d
Cleared May 21, 2017
LT-300 SD Digital Video Colposcope
K170446 · HEX
Lutech Industries, Inc.
Obstetrics & Gynecology · 96d
Cleared May 18, 2017
LaparoLight Veress Needle
K171139 · HIF
Buffalo Filter, LLC
Obstetrics & Gynecology · 30d
Cleared May 15, 2017
PNEUMOCLEAR
K170784 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 61d
Cleared May 12, 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems...
K161261 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 373d
Cleared May 11, 2017
Kitazato IUI Catheter
K162667 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 227d
Cleared May 04, 2017
Restore Moisturizing Vaginal Lubricant
K162207 · NUC
Good Clean Love
Obstetrics & Gynecology · 272d
Cleared Apr 28, 2017
BabyDance Fertility Lubricant
K162319 · PEB
Fairhaven Health, LLC
Obstetrics & Gynecology · 252d
Cleared Apr 04, 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · MQL
CooperSurgical, Inc.
Obstetrics & Gynecology · 36d
Cleared Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation...
K170622 · OQY
Cook Incorporated
Obstetrics & Gynecology · 30d
Cleared Mar 24, 2017
LUVENA VAGINAL MOISTURIZER & LUBRICANT
K162235 · NUC
Laclede, Inc.
Obstetrics & Gynecology · 227d
Cleared Mar 21, 2017
LAP-Pump PP110
K163320 · HET
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 118d
Cleared Mar 15, 2017
Spectra 9Plus
K162415 · HGX
Uzinmedicare Company
Obstetrics & Gynecology · 198d
Cleared Mar 09, 2017
Transem and EchoGen Embryo Transfer Catheters
K161547 · MQF
Origio A/S
Obstetrics & Gynecology · 279d
Cleared Mar 07, 2017
CIMLRE F1 and CIMILRE S3
K162870 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 145d
Cleared Mar 07, 2017
Male Latex Condoms
K162919 · HIS
Zhejiang Xiangban Latex Products Co.,...
Obstetrics & Gynecology · 140d