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
385–408 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Apr 28, 2022
Microthin Natural Rubber Latex Condom
K213921 · HIS
Suretex Limited
Obstetrics & Gynecology · 134d
Cleared Apr 22, 2022
Lorals
K212928 · MSC
Brazen Goods Inc. Dba Lorals
Obstetrics & Gynecology · 220d
Cleared Apr 21, 2022
Tempo Tampon
K212277 · HEB
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology · 275d
Cleared Apr 15, 2022
ARDO Alyssa
K212773 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 227d
Cleared Apr 13, 2022
Sensuva Premium Silicone Personal Lubricant
K212260 · NUC
Valencia Naturals, Inc.
Obstetrics & Gynecology · 267d
Cleared Apr 05, 2022
Apyx
K213783 · PBQ
Escala Medical
Obstetrics & Gynecology · 123d
Cleared Mar 31, 2022
Alexis Contained Extraction System
K211043 · GCJ
Applied Medical Resources Corporation
Obstetrics & Gynecology · 357d
Cleared Mar 31, 2022
Uterine ElevatOR PRO with OccludOR Balloon
K220202 · LKF
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 66d
Cleared Mar 28, 2022
SancDam Latex Oral Dam
K212037 · MSC
Sanctuary Health Sdn. Bhd.
Obstetrics & Gynecology · 271d
Cleared Mar 15, 2022
Fit Pro Breast Pump
K212955 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 180d
Cleared Mar 11, 2022
EmbryoSlide+ ic8 dish
K213869 · MQK
Vitrolife A/S
Obstetrics & Gynecology · 88d
Cleared Mar 03, 2022
Astroglide Sensual Strawberry Personal Lubricant
K213671 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 101d
Cleared Mar 01, 2022
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,...
K213400 · NUC
Rb Health (Us)
Obstetrics & Gynecology · 134d
Cleared Feb 25, 2022
Okamoto 002 Lubricated Polyurethane Male Condom
K203541 · MOL
Okamoto USA, Inc.
Obstetrics & Gynecology · 449d
Cleared Feb 25, 2022
Cohitech Cottonlock Tampons with Reusable Applicator
K220238 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 28d
Cleared Feb 23, 2022
LevaLap Laparoscopic Access Device
K212786 · HIF
Core Access Surgical Technologies, Inc.
Obstetrics & Gynecology · 175d
Not Cleared Feb 23, 2022
ONE Male Condom
DEN210034 · QRZ
Global Protection Corp.
Obstetrics & Gynecology · 181d
Cleared Feb 17, 2022
Titan Condoms
K210208 · HIS
Titan Condoms, LLC
Obstetrics & Gynecology · 387d
Cleared Feb 17, 2022
Durex Patronus Wide
K213647 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Feb 11, 2022
Electric Breast Pump
K211024 · HGX
Shantou Huihengqi Electronic...
Obstetrics & Gynecology · 311d
Cleared Feb 11, 2022
Wearable Breast Pump (Model S12)
K212180 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Feb 11, 2022
Actively Trying Personal Lubricant Rose Scented
K212885 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 154d
Cleared Feb 09, 2022
Actively Trying Personal Lubricant Unfragrance
K212705 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 167d
Cleared Feb 09, 2022
Lucy Breast Pump
K213311 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 128d