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
889–912 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Nov 20, 2015
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
K150525 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 263d
Cleared Nov 19, 2015
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
K150094 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 307d
Cleared Nov 13, 2015
MAKO Device
K151275 · HIH
Nvision Medical
Obstetrics & Gynecology · 184d
Cleared Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 52d
Cleared Nov 12, 2015
Water Based Personal Lubricant with Flavours
K150743 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 234d
Cleared Nov 09, 2015
Divine 9
K150397 · NUC
Carrashield Labs, Inc.
Obstetrics & Gynecology · 264d
Cleared Nov 06, 2015
Breast Pump
K150923 · HGX
Guangzhou Jinxinbao Electronic Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Nov 05, 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump,...
K151632 · HGX
Medela AG
Obstetrics & Gynecology · 141d
Cleared Nov 02, 2015
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light...
K151470 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 154d
Not Cleared Nov 02, 2015
INVOcell
DEN150008 · OYO
Invo Bioscience
Obstetrics & Gynecology · 252d
Cleared Oct 20, 2015
Swiss Navy Premium Silicone Lubricant
K150153 · NUC
Package Solutions, LLC
Obstetrics & Gynecology · 270d
Cleared Oct 13, 2015
GelPOINT Transvaginal Access Platform
K143308 · HEW
Applied Medical Resources
Obstetrics & Gynecology · 329d
Cleared Oct 01, 2015
VISERA 4K UHD SYSTEM
K151011 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 169d
Cleared Sep 23, 2015
Uberlube
K151647 · NUC
Uberlube, LLC
Obstetrics & Gynecology · 97d
Cleared Sep 23, 2015
Sydney IVF PVP
K152440 · MQL
Willam A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 27d
Cleared Sep 18, 2015
Circumplast Circumcision Device
K151095 · HFX
Novadien Healthcare
Obstetrics & Gynecology · 148d
Cleared Sep 16, 2015
Gynomunal
K143349 · NUC
Polichem S.A
Obstetrics & Gynecology · 296d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 30d
Cleared Sep 01, 2015
HyaloGYN Vaginal Hydrating Gel
K150883 · NUC
Fidia Farmaceutici S.P.A.
Obstetrics & Gynecology · 152d
Cleared Aug 28, 2015
UTAH CVX-RIPE
K143424 · PFJ
Utah Medical Products, Inc.
Obstetrics & Gynecology · 270d
Cleared Aug 27, 2015
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst...
K143724 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 241d
Cleared Aug 21, 2015
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal...
K143529 · NUC
Medline Industries, Inc.
Obstetrics & Gynecology · 252d
Cleared Aug 19, 2015
ManipulatOR PRO, ManipulatOR
K150519 · LKF
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 170d
Cleared Aug 14, 2015
Banana Gold
K150857 · HIS
Hankook Latex Gongup Co., Ltd.
Obstetrics & Gynecology · 136d