HGX · Class II · 21 CFR 884.5160

FDA Product Code HGX: Pump, Breast, Powered

Leading manufacturers include Shenzhen TPH Technology Co., Ltd., Shenzhen Root Innovation Technology Co., Ltd. and Medela, Inc..

250
Total
250
Cleared
168d
Avg days
1980
Since
250 devices
145–168 of 250
Cleared Jul 31, 2017
Youha electric breast pump
K163136
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Obstetrics & Gynecology · 265d
Cleared Mar 15, 2017
Spectra 9Plus
K162415
Uzinmedicare Company
Obstetrics & Gynecology · 198d
Cleared Mar 07, 2017
CIMLRE F1 and CIMILRE S3
K162870
Cimilre Co., Ltd.
Obstetrics & Gynecology · 145d
Cleared Dec 08, 2016
Proture Double Electric Breast Pump
K162747
Guangdong Horigen Mother & Baby Products Co., Ltd.
Obstetrics & Gynecology · 69d
Cleared Oct 28, 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
K161725
Medela, Inc.
Obstetrics & Gynecology · 128d
Cleared Sep 01, 2016
Hi bebe plus
K160274
Bistos Co., Ltd.
Obstetrics & Gynecology · 212d
Cleared Aug 29, 2016
Philips Avent Comfort Single/Twin Electric Breast Pump
K161532
Philips Consumer Lifestyle - Innovation Site Eindhoven
Obstetrics & Gynecology · 88d
Cleared Aug 11, 2016
Athena Breast Pump
K161266
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 98d
Cleared Jun 24, 2016
Naya Breast Pump System
K160511
Naya Health, Inc.
Obstetrics & Gynecology · 121d
Cleared Apr 15, 2016
Spectra S1Plus and Spectra S2 Plus
K150476
Uzinmedicare Co.
Obstetrics & Gynecology · 416d
Cleared Dec 21, 2015
Electric Double Breast Pumps
K151284
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Obstetrics & Gynecology · 221d
Cleared Nov 06, 2015
Breast Pump
K150923
Guangzhou Jinxinbao Electronic Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Nov 05, 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
K151632
Medela AG
Obstetrics & Gynecology · 141d
Cleared Jun 17, 2015
ARDO Calypso Pro Powered Breast Pump
K150721
Ardo Medical AG
Obstetrics & Gynecology · 90d
Cleared May 06, 2015
Electric Breast Pump
K143585
Shantou Xinghe Electrical Apparatuses Co., Ltd.
Obstetrics & Gynecology · 139d
Cleared Apr 21, 2015
Melodi Prime Breast Pump
K143574
Genadyne Biotechnologies, Inc.
Obstetrics & Gynecology · 125d
Cleared Apr 21, 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K150499
Medela AG
Obstetrics & Gynecology · 54d
Cleared Feb 24, 2015
MEGNA BREAST PUMPS
K142479
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Obstetrics & Gynecology · 173d
Cleared Feb 20, 2015
PJ'S SERENITY
K132220
Limerick, Inc.
Obstetrics & Gynecology · 583d
Cleared Dec 04, 2014
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168
Devon Medical Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Oct 17, 2014
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
K141742
Ardo Medical AG
Obstetrics & Gynecology · 112d
Cleared Apr 24, 2014
ELECTRIC BREAST PUMP
K132882
Shantou Xinghe Electrical Apparatuses Co., Ltd.
Obstetrics & Gynecology · 223d
Cleared Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
K130349
Dao Health
Obstetrics & Gynecology · 206d
Cleared Jun 18, 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153
Evenflo Feeding Incorporated
Obstetrics & Gynecology · 55d