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, LLC.

239
Total
239
Cleared
166d
Avg days
1980
Since
239 devices
73–96 of 239
Cleared May 26, 2023
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
K223329
Guangzhou Yongyi Industrial Co., Ltd.
Obstetrics & Gynecology · 207d
Cleared Mar 30, 2023
ARDO Bellis
K230590
Ardo Medical AG
Obstetrics & Gynecology · 27d
Cleared Mar 16, 2023
MilkMate Breast Pump
K223084
Milkmate Products, Inc.
Obstetrics & Gynecology · 167d
Cleared Mar 09, 2023
Electric breast pump (model: M5)
K223693
Shenzhen Lutejiacheng Technology Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Mar 03, 2023
imani i2Plus Breast Pump
K222573
Imani Co.
Obstetrics & Gynecology · 190d
Cleared Jan 13, 2023
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199
K222782
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 120d
Cleared Jan 04, 2023
Wearable Breast Pump (Model S1DW)
K222045
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Dec 23, 2022
CIMILRE Free-T2 Plus
K221708
Cimilre Co., Ltd.
Obstetrics & Gynecology · 193d
Cleared Dec 23, 2022
Smartpump 3.0 Double Electric Breast Pump
K222726
Lansinoh Laboratories
Obstetrics & Gynecology · 106d
Cleared Dec 12, 2022
Spectra Wearable
K220926
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 256d
Cleared Dec 09, 2022
Wearable breast pump
K221598
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d
Cleared Oct 12, 2022
Ameda Pearl Electric Breast Pump
K221576
Ameda, Inc.
Obstetrics & Gynecology · 133d
Cleared Jun 29, 2022
Powered Breast Pump (Models 7V and 7X)
K211016
Haenim Co., Ltd.
Obstetrics & Gynecology · 450d
Cleared Jun 27, 2022
Wearable Breast Pump (Model S10)
K220309
Shenzhen Lutejiacheng Technology Co., Ltd.
Obstetrics & Gynecology · 145d
Cleared May 26, 2022
Wearable Breast Pump (Model S9)
K220596
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared May 06, 2022
Electric Breast Pump
K212564
Guangdong Horigen Mother & Baby Products Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Apr 15, 2022
ARDO Alyssa
K212773
Ardo Medical AG
Obstetrics & Gynecology · 227d
Cleared Mar 15, 2022
Fit Pro Breast Pump
K212955
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 180d
Cleared Feb 11, 2022
Electric Breast Pump
K211024
Shantou Huihengqi Electronic Technology Co., Ltd.
Obstetrics & Gynecology · 311d
Cleared Feb 11, 2022
Wearable Breast Pump (Model S12)
K212180
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Feb 09, 2022
Lucy Breast Pump
K213311
Willow Innovations, Inc.
Obstetrics & Gynecology · 128d
Cleared Jan 20, 2022
Electric breast pump
K212884
Dongguan Rongfeng Medical Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Dec 01, 2021
Electric Breast Pump
K211755
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Oct 19, 2021
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
K210124
Uzinmedicare Co.
Obstetrics & Gynecology · 273d