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
145–168 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared May 22, 2025
Harioculture TL-16 Time-lapse Incubator
K242684 · MQG
Hua Yue Medical Technology Co., Ltd.
Obstetrics & Gynecology · 258d
Cleared May 22, 2025
Koala Intrauterine Pressure Catheter (IPC-5000E)
K250897 · HFN
Clinical Innovations, LLC
Obstetrics & Gynecology · 58d
Cleared May 09, 2025
Water Solubility Human Body Lubricant
K243107 · NUC
Dongguan Yanxuan Biotechnology Co., Ltd.
Obstetrics & Gynecology · 221d
Cleared May 02, 2025
Sutil Rich Personal Lubricant
K250629 · NUC
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology · 60d
Cleared Apr 25, 2025
i-Cut
K243821 · HET
A.M.I. Agency For Medical Innovations...
Obstetrics & Gynecology · 134d
Cleared Apr 21, 2025
Wearable breast pump (model S12A)
K243508 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 160d
Cleared Apr 17, 2025
Lacevo Wearable Breast Pump (Model S70)
K250829 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 29d
Cleared Apr 15, 2025
LapBox Power Tissue Containment System
K250212 · PMU
Ark Surgical
Obstetrics & Gynecology · 81d
Cleared Apr 11, 2025
AirSurgN Insufflator (10030/AirSurgN)
K242772 · HIF
Smartsurgn, Inc.
Obstetrics & Gynecology · 210d
Cleared Apr 11, 2025
CooperSurgical Milex® Pessaries
K250438 · HHW
CooperSurgical, Inc.
Obstetrics & Gynecology · 56d
Cleared Apr 10, 2025
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089 · MQL
Jiangsu Ruifuda Medical Device Co., Ltd.
Obstetrics & Gynecology · 267d
Cleared Apr 10, 2025
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 225d
Cleared CT Apr 08, 2025
ONE Nitrile Condom
K243967 · MOL
Global Protection Corp.
Obstetrics & Gynecology · 106d
Cleared Apr 02, 2025
Béa Applicator (BAP-GB-01)
K242031 · HDR
Stepone Fertility Ltd (T/A B?a...
Obstetrics & Gynecology · 265d
Cleared Apr 02, 2025
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
K250152 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 71d
Cleared Apr 02, 2025
Sonata Transcervical Fibroid Ablation System 2.2
K250705 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 23d
Cleared Apr 01, 2025
SABA Tampons
K242105 · HEB
Essity Higiene Y Salud Mexico. S.A....
Obstetrics & Gynecology · 257d
Cleared Mar 21, 2025
V-GRAD
K241833 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 269d
Cleared Mar 21, 2025
CaseMONO™ Culture (CMON)
K242107 · MQL
Casebioscience, Inc.
Obstetrics & Gynecology · 246d
Cleared Mar 21, 2025
Natural Cycles
K250561 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 24d
Cleared Mar 20, 2025
Joylux Intimacy Gel (PG3100)
K242958 · NUC
Joylux, Inc.
Obstetrics & Gynecology · 176d
Cleared Mar 20, 2025
Ameda GLO Wearable Breast Pump (Model W8S)
K250463 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Mar 07, 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 123d
Cleared Feb 28, 2025
Durex Polyisoprene Condom
K241617 · MOL
Rb Health (Us), LLC
Obstetrics & Gynecology · 268d