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
817–840 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Oct 07, 2016
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 192d
Cleared Oct 07, 2016
PK Morcellator
K161038 · GEI
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 177d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217 · LKF
Cook Incorporated
Obstetrics & Gynecology · 251d
Cleared Sep 14, 2016
Colposcope System
K160341 · HEX
Xuzhou Kernel Medical Equipment Co.,...
Obstetrics & Gynecology · 219d
Cleared Sep 09, 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe...
K161915 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 59d
Cleared Sep 07, 2016
Central Monitoring System
K153580 · HGM
Guangdong Biolight Meditech Co., Ltd.
Obstetrics & Gynecology · 267d
Cleared Sep 06, 2016
Mano and Mano Personal Lubricant
K161585 · NUC
Mano and Mano Proprietary Limited
Obstetrics & Gynecology · 90d
Cleared Sep 01, 2016
Hi bebe plus
K160274 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 212d
Cleared CT Aug 31, 2016
Trojan Chain Reaction Personal Lubricant
K161544 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 89d
Cleared Aug 29, 2016
Philips Avent Comfort Single/Twin Electric Breast Pump
K161532 · HGX
Philips Consumer Lifestyle -...
Obstetrics & Gynecology · 88d
Cleared Aug 26, 2016
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe...
K161545 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 84d
Cleared Aug 25, 2016
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
K161195 · HIS
M3 Global Enterprises, LLC
Obstetrics & Gynecology · 120d
Cleared Aug 17, 2016
Just Like Me Personal Lubricant
K161385 · NUC
Wtfn-Dba Classic Erotica/Holiday...
Obstetrics & Gynecology · 90d
Cleared Aug 15, 2016
Sydney IVF Gamete Buffer
K153478 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 257d
Cleared Aug 11, 2016
Athena Breast Pump
K161266 · HGX
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 98d
Cleared Aug 05, 2016
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator...
K161877 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 01, 2016
Aqueduct 100 Cervical Dilator
K160664 · PON
Gtimd, LLC
Obstetrics & Gynecology · 145d
Cleared Jul 28, 2016
PBS(-), Phosphate Buffered Saline
K160863 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 121d
Cleared Jul 25, 2016
Skyn Original Polyisoprene Lubricated Male Condom
K160399 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 164d
Cleared Jul 22, 2016
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm...
K153267 · MQL
Origio A/S
Obstetrics & Gynecology · 253d
Cleared Jul 18, 2016
RI Witness Embryology Heated Plate
K160504 · MQG
Research Instruments Limited
Obstetrics & Gynecology · 145d
Cleared Jul 14, 2016
Panpac Disposable Pessary Fitting Set
K153422 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 232d
Cleared Jul 11, 2016
Pulse H20h!
K152628 · NUC
Toaster Labs, Inc.
Obstetrics & Gynecology · 300d
Cleared Jul 11, 2016
Pulse Aloe-ahh
K152671 · NUC
Toaster Labs, Inc.
Obstetrics & Gynecology · 297d