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
625–648 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared May 08, 2019
Gynescope System
K190187 · HEX
Illumigyn , Ltd.
Obstetrics & Gynecology · 96d
Cleared Apr 26, 2019
JO Actively Trying Personal Lubricant
K182585 · PEB
United Consortium
Obstetrics & Gynecology · 218d
Cleared Apr 25, 2019
Smile Makers Personal Lubricant
K182100 · NUC
Lfbeauty (Thailand) Limited
Obstetrics & Gynecology · 265d
Cleared Apr 24, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope,...
K190113 · HIH
Corinth Medtech, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 17, 2019
JO H2O Jelly Original Personal Lubricant
K183584 · NUC
United Consortium
Obstetrics & Gynecology · 117d
Cleared Apr 16, 2019
KY Banksy Aloe
K183302 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 140d
Cleared Apr 15, 2019
One Touch
K181844 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 278d
Cleared Mar 29, 2019
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
K181770 · LKF
Cook Incorporated
Obstetrics & Gynecology · 269d
Cleared Mar 15, 2019
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
K182813 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 163d
Cleared Mar 07, 2019
Electric Breast Pump
K182413 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 184d
Cleared Mar 04, 2019
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant,...
K183384 · NUC
United Consortium
Obstetrics & Gynecology · 88d
Cleared Mar 01, 2019
Fetal Doppler, Model FD88
K182710 · KNG
Shenzzhen Luckcome Technology Inc., Ltd.
Obstetrics & Gynecology · 155d
Cleared Jan 31, 2019
Endosee System
K183020 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 04, 2019
Rapid-i™ Kit
K181461 · MQK
Vitrolife Sweden AB
Obstetrics & Gynecology · 214d
Cleared Jan 04, 2019
Polygon Resection Device
K182675 · HIH
Polygon Medical, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 21, 2018
Creme de La Femme Feminine Lubricant
K180014 · NUC
Cewal, Inc. Dba Premiere Enterprises
Obstetrics & Gynecology · 353d
Cleared Dec 20, 2018
Natureplex Warm Touch Warming Jelly
K180828 · NUC
Natureplex, LLC
Obstetrics & Gynecology · 265d
Cleared Dec 19, 2018
Fetal Doppler
K182190 · KNG
Shenzhen AOJ Medical Technology Co.,...
Obstetrics & Gynecology · 128d
Cleared Dec 06, 2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 132d
Cleared Dec 06, 2018
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K182438 · MOL
Sxwell USA, LLC
Obstetrics & Gynecology · 90d
Cleared Nov 30, 2018
Spectra S3 Plus
K181784 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 150d
Cleared Nov 27, 2018
Biop Digital Colposcope
K182764 · HEX
Biop Medical , Ltd.
Obstetrics & Gynecology · 60d
Cleared Nov 21, 2018
Wet Organics Personal Lubricant
K182027 · NUC
Trigg Laboratories Dba Wet International
Obstetrics & Gynecology · 114d
Cleared Nov 14, 2018
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored...
K182105 · NUC
United Consortium
Obstetrics & Gynecology · 103d