FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Obstetrics & Gynecology ×
4,499 results
625–648 of 4,499
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
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
Cleared Aug 15, 2018
Sonata Sonography-Guided Transcervical Fibroid Ablation System
K173703 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 254d
Not Cleared Aug 10, 2018
Natural Cycles
DEN170052 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 324d