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
649–672 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Nov 09, 2018
Cryotop®US-flash and Cryotop®US-scoop
K181469 · MQK
Kitazato Corporation
Obstetrics & Gynecology · 158d
Cleared Nov 02, 2018
Interlude 100% Cotton Tampon
K181911 · HEB
Albaad Fem
Obstetrics & Gynecology · 108d
Cleared Oct 31, 2018
Panpac Flexi Shelf Pessary
K173351 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 371d
Cleared Oct 31, 2018
Endomat Select
K180735 · HIG
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 223d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291 · LKF
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · LKF
Cook Incorporated
Obstetrics & Gynecology · 266d
Cleared Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™...
K180302 · MQF
Cook Incorporated
Obstetrics & Gynecology · 264d
Cleared Oct 23, 2018
Cumulus Remover
K182002 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 89d
Cleared Oct 16, 2018
Pump In Style Advanced, Advanced Personal Double Breastpump
K181937 · HGX
Medela, LLC
Obstetrics & Gynecology · 89d
Cleared Oct 10, 2018
Elvie Pump
K181863 · HGX
Chiaro Technology Limited
Obstetrics & Gynecology · 90d
Cleared Sep 28, 2018
Acessa ProVu System
K181124 · HFG
Acessa Health, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034 · HEX
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared Sep 20, 2018
NICO Myriad
K182340 · GEI
Nico Corporation
Obstetrics & Gynecology · 23d
Cleared Sep 17, 2018
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K173871 · NAJ
Suzhou Hengrui Callisyn Biomedical...
Obstetrics & Gynecology · 271d
Cleared Sep 11, 2018
Anchor Tissue Retrieval System by CONMED
K173822 · GCJ
Conmed Corporation
Obstetrics & Gynecology · 267d
Cleared Sep 10, 2018
IntelliSpace Perinatal Rev.K.00
K173941 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 258d
Cleared Sep 10, 2018
The Sex Gel
K181078 · NUC
Necessaire, Inc.
Obstetrics & Gynecology · 139d
Cleared Aug 30, 2018
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 336d
Cleared Aug 29, 2018
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073 · MQL
Shenzhen Vitavitro Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 232d
Cleared Aug 29, 2018
TruClear Elite Hysteroscope
K180496 · HIH
Covidien
Obstetrics & Gynecology · 184d
Cleared Aug 27, 2018
JO Classic Hybrid Personal Lubricant
K181408 · NUC
United Consortium
Obstetrics & Gynecology · 89d
Cleared Aug 23, 2018
MyoSure XL Tissue Removal Device for Fluent
K181974 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 30d
Cleared Aug 20, 2018
re.t.a Reuseable Tampon Applicator
K180850 · HEB
Thinx, Inc.
Obstetrics & Gynecology · 140d
Cleared Aug 16, 2018
Luminelle DTx Hysteroscopy System
K181909 · FAJ
Uvision360, Inc.
Obstetrics & Gynecology · 30d