FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Obstetrics & Gynecology ×
4,507 results
553–576 of 4,507
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Nov 18, 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
K190797 · HIH
Reed Medical (Zhejiang) Co., Ltd.
Obstetrics & Gynecology · 235d
Cleared Nov 14, 2019
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip...
K190522 · MQF
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 255d
Cleared Nov 14, 2019
HeraBEAT™ US
K191110 · KNG
Heramed, Ltd.
Obstetrics & Gynecology · 202d
Cleared Nov 07, 2019
BioGenesis Fertility Lubricant
K190872 · PEB
Good Clean Love, Inc.
Obstetrics & Gynecology · 218d
Cleared Nov 01, 2019
WV1 Endoscope
K190190 · HET
270surgical , Ltd.
Obstetrics & Gynecology · 273d
Cleared Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable...
K192278 · HIH
Uvision360, Inc.
Obstetrics & Gynecology · 71d
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