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Panels › Obstetrics/Gynecology › Product code HGX · Class 2

Pump, Breast, Powered

Regulation 884.5160

38510(k)s in 12 months (254 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in HGX

Company510(k)sRecalls
Medela AG196
Shenzhen TPH Technology Co., Ltd.240
Uzinmedicare Co.120
Shenzhen Root Innovation Technology Co., Ltd.110
Evenflo Co., Inc.90
Guangdong Horigen Mother & Baby Products Co., Ltd.60
Ardo Medical AG50
Crystal Medical Products, Inc.40
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.40
Guangdong Youmeng Electrical Technology Co., Ltd.40
Decided510(k)Device and applicantCode
Jun 27, 2022K220309Wearable Breast Pump (Model S10)
Shenzhen Lutejiacheng Technology Co., Ltd., CN
HGX
May 26, 2022K220596Wearable Breast Pump (Model S9)
Shenzhen TPH Technology Co., Ltd., CN
HGX
May 6, 2022K212564Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd., CN
HGX
Apr 15, 2022K212773ARDO Alyssa
Ardo Medical AG, CH
HGX
Mar 15, 2022K212955Fit Pro Breast Pump
Hygeia II Medical Group, Inc.
HGX
Feb 11, 2022K212180Wearable Breast Pump (Model S12)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Feb 11, 2022K211024Electric Breast Pump
Shantou Huihengqi Electronic Technology Co., Ltd., CN
HGX
Feb 9, 2022K213311Lucy Breast Pump
Willow Innovations, Inc.
HGX
Jan 20, 2022K212884Electric breast pump
Dongguan Rongfeng Medical Co., Ltd., CN
HGX
Dec 1, 2021K211755Electric Breast Pump
Zhejiang Carebao Co., Ltd., CN
HGX
Oct 19, 2021K210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)
Uzinmedicare Co., KR
HGX
Aug 26, 2021K202802TT Electric Breast Pump, TT Double Electric Breast Pump
Wuxi Xinzhongrui Baby Supplies Co., Ltd., CN
HGX
Aug 25, 2021K210936Elvie Stride
Chiaro Technology Limited, GB
HGX
Aug 11, 2021K210759Solo, Swing Maxi
Medela, LLC
HGX
Jul 8, 2021K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: B
Ningbo Youhe Electrical Appliance Technology Co., Ltd., CN
HGX
May 4, 2021K201152Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd., CN
HGX
Apr 22, 2021K203570Mya Joy PLUS Breast Pump
Ameda, Inc.
HGX
Apr 9, 2021K201903Electric breast pump (Models: RH-228 and RH-338)
Cixi Ruihong Electric Appliance Co., Ltd., CN
HGX
Mar 1, 2021K202037imani i2
Imani Co., KR
HGX
Feb 26, 2021K202045imani i1
Imani Co., KR
HGX
Feb 10, 2021K200675Hi bebe super (Models BT-150S and BT-150L)
Bistos Co., Ltd., KR
HGX
Dec 15, 2020K203383Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/
Philips Consumer Lifestyle - Innovation Site Eindhoven, NL
HGX
Oct 1, 2020K201381Philips Avent Single/Double electric breast pump Advanced
Philips Consumer Lifestyle - Innovation Site Eindhoven, NL
HGX
Sep 11, 2020K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
Guangdong Horigen Mother & Baby Products Co., Ltd., CN
HGX
Jun 15, 2020K200508Pump In Style
Medela, LLC
HGX
Apr 17, 2020K200712Rumble Tuff Electric Breast Pump
A Cute Baby, Inc.
HGX
Mar 30, 2020K192640Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
Guangzhou Yongyi Industrial Co., Ltd., CN
HGX
Mar 18, 2020K200406Evolve Breast Pump
Hygeia II Medical Group, Inc.
HGX
Jan 22, 2020K191109Spectra Q
Uzinmedicare Co., KR
HGX
Jan 16, 2020K191802Electric Breast Pump
Ningbo Huiyoo Baby Products Co., Ltd., CN
HGX
Oct 18, 2019K190465Evolve Breast Pump
Hygeia II Medical Group, Inc.
HGX
Oct 17, 2019K191653Freestyle Flex
Medela AG, CH
HGX
Oct 11, 2019K191208Spectra Cashmere
Uzinmedicare Co., KR
HGX
Sep 6, 2019K191577Willow Wearable Breast Pump 2.0
Exploramed Nc7, Inc.
HGX
Aug 30, 2019K190810OPERA, OPERA eco
Unimom.Co, KR
HGX
Jun 12, 2019K182749Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd., TR
HGX
Mar 7, 2019K182413Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd., CN
HGX
Nov 30, 2018K181784Spectra S3 Plus
Uzinmedicare Co., KR
HGX
Oct 16, 2018K181937Pump In Style Advanced, Advanced Personal Double Breastpump
Medela, LLC
HGX
Oct 10, 2018K181863Elvie Pump
Chiaro Technology Limited, GB
HGX
Aug 6, 2018K180075MINUET LCD, MINUET LCD eco
Unimom.Co, KR
HGX
Jun 18, 2018K172842GCE704 Breast Pump
Globalcare, CN
HGX
Apr 4, 2018K173699The Pump by Babyation
Babyation, LLC
HGX
Dec 20, 2017K172989Electric Breast Pump
Joytech Healthcare Co. , Ltd., CN
HGX
Nov 29, 2017K172067One Mum Pumpset
Ardo Medical AG, CH
HGX
Oct 13, 2017K172772Freemie Independence, Freemie Liberty
Dao Health
HGX
Oct 2, 2017K163183Yooeehouse Breast Pump
Nantong Poly Technology Co., Ltd., CN
HGX
Aug 28, 2017K170722Moxxly Flow Collection System
Moxxly, Inc.
HGX
Jul 31, 2017K163136Youha electric breast pump
Ningbo Youhe Electrical Appliance Technology Co., Ltd., CN
HGX
Mar 15, 2017K162415Spectra 9Plus
Uzinmedicare Company, KR
HGX

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