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
337–360 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Jan 06, 2023
U by Kotex® Click® Unscented Menstrual Tampons
K223749 · HEB
Kimberly Clark Corporation
Obstetrics & Gynecology · 23d
Cleared Jan 04, 2023
Wearable Breast Pump (Model S1DW)
K222045 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Dec 23, 2022
CIMILRE Free-T2 Plus
K221708 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 193d
Cleared Dec 23, 2022
Smartpump 3.0 Double Electric Breast Pump
K222726 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 106d
Cleared Dec 16, 2022
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · MQF
Shanghai Horizon Medical Technology...
Obstetrics & Gynecology · 346d
Cleared Dec 16, 2022
Rejoni Intrauterine Catheter
K222798 · LKF
Rejoni, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 12, 2022
Spectra Wearable
K220926 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 256d
Cleared Dec 09, 2022
Wearable breast pump
K221598 · HGX
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d
Cleared Nov 28, 2022
Male Latex Condoms
K222611 · HIS
Suzhou Colour-Way New Material Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Nov 18, 2022
Konig Mogen Clamp
K212911 · HFX
Medline Industries, Inc.
Obstetrics & Gynecology · 431d
Cleared Nov 15, 2022
Bloomi Delight Oil-Based Personal Lubricant
K222175 · NUC
The Bloomi Inc..
Obstetrics & Gynecology · 117d
Cleared Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 99d
Cleared Nov 07, 2022
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 258d
Cleared Nov 04, 2022
CryoRobot Select System
K221086 · QUJ
Tmrw Life Sciences, Inc.
Obstetrics & Gynecology · 205d
Cleared Oct 31, 2022
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
K221810 · MQK
Bonraybio Co., Ltd.
Obstetrics & Gynecology · 131d
Cleared Oct 28, 2022
ALLY II Uterine Positioning System™ (UPS)
K223064 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098 · OQY
Cook Incorporated
Obstetrics & Gynecology · 28d
Cleared Oct 21, 2022
Onetouch Non-paraben Lubricant Gel
K220273 · NUC
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 263d
Cleared Oct 12, 2022
Ameda Pearl Electric Breast Pump
K221576 · HGX
Ameda, Inc.
Obstetrics & Gynecology · 133d
Cleared Oct 12, 2022
Durex Penck III Regular
K222068 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Sep 30, 2022
OFNat Lubricant (L15)
K221243 · NUC
Suretex Limited
Obstetrics & Gynecology · 151d
Cleared Sep 30, 2022
Unscented Menstrual Tampon
K222046 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 81d
Cleared Sep 28, 2022
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · KNG
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 243d
Cleared Sep 28, 2022
TROJAN Fire & Ice lubricated male natural rubber latex condom
K221906 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d