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
577–600 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · OQY
Ujenzi Charitable Trust
Obstetrics & Gynecology · 173d
Cleared Oct 18, 2019
Evolve Breast Pump
K190465 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 234d
Cleared Oct 17, 2019
Freestyle Flex
K191653 · HGX
Medela AG
Obstetrics & Gynecology · 119d
Cleared Oct 11, 2019
Spectra Cashmere
K191208 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 158d
Cleared Oct 11, 2019
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum...
K191480 · NUC
Trigg Laboratories, Inc. D/B/A Wet...
Obstetrics & Gynecology · 129d
Cleared Oct 07, 2019
Interlude Rolled Tampons in Plastic Applicator
K191431 · HEB
Albaad Fem
Obstetrics & Gynecology · 131d
Cleared Oct 01, 2019
Aveta System
K191958 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 70d
Cleared Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
K190199 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 234d
Cleared Sep 25, 2019
3D Visualization System
K183675 · GCJ
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 271d
Cleared Sep 25, 2019
Aloe Glide Lubricant
K190323 · NUC
Desert Harvest, Inc.
Obstetrics & Gynecology · 224d
Cleared Sep 18, 2019
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA...
K190858 · NUC
United Consortium
Obstetrics & Gynecology · 169d
Cleared Sep 18, 2019
GM501 Mineral Oil
K191552 · MQL
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 13, 2019
NICO Myriad NOVUS
K191599 · GEI
Nico Corporation
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2019
Transvaginal Access Platform
K191294 · HEW
Applied Medical Resources Corp.
Obstetrics & Gynecology · 115d
Cleared Sep 06, 2019
Willow Wearable Breast Pump 2.0
K191577 · HGX
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 84d
Cleared Sep 05, 2019
GM501 Wash
K190383 · MQL
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 198d
Cleared Aug 30, 2019
OPERA, OPERA eco
K190810 · HGX
Unimom.Co
Obstetrics & Gynecology · 154d
Cleared Aug 29, 2019
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
K190744 · HET
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 160d
Cleared Aug 29, 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 108d
Cleared Aug 28, 2019
FEMME Applicator Tampon
K182142 · HEB
Jiangsu Yoai Technology Co., Ltd.
Obstetrics & Gynecology · 386d
Cleared Aug 28, 2019
AP50/30 Insufflator with Insuflow Port
K191780 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 57d
Cleared Aug 23, 2019
CrossBay Cervical Dilator Catheter System
K190813 · PON
Crossbay Medical
Obstetrics & Gynecology · 147d
Cleared Aug 23, 2019
1-Step Culture Medium
K191063 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 123d
Cleared Aug 01, 2019
JO Premium Jelly Original Personal Lubricant
K191214 · NUC
United Consortium
Obstetrics & Gynecology · 87d