Pump, Breast, Powered

FDA product code HGX · 241 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.5160
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-10-03 – 2026-09-17

HGX 2026-09-17

Wearable Breast Pump (Model S36)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K254203

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HGX 2026-09-03

Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)

Applicant Philips Consumer Lifestyle B.V.

K number K261622

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HGX 2026-09-01

Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K262774

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HGX 2026-08-21

Cimilre Dual Max

Applicant Cimilre Co., Ltd.

K number K260643

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HGX 2026-08-20

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K number K261298

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HGX 2026-07-24

DiscreetDuo™ Flow Wearable Breast Pump (Model S3)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K260259

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HGX 2026-07-13

Wearable Breast Pump (Model S32A)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K261199

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HGX 2026-06-26

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

Applicant Shenzhen Changkun Technology Co., Ltd.

K number K250070

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HGX 2026-06-25

Wearable breast pump (QY-101, QY-102, QY-108)

Applicant Shenzhen Qinyi Electronic Technology Co., Ltd.

K number K261025

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HGX 2026-06-18

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K254254

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HGX 2026-06-17

Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K260538

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HGX 2026-06-12

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

Applicant Polybell (Guangzhou) Limited

K number K260346

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HGX 2026-06-11

AViTA Breast Pump

Applicant Avita Corporation

K number K250129

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HGX 2026-06-09

Mother's Nature W1 Warming Wearable Breast Pump

Applicant Shenzhen TPH Technology Co., Ltd.

K number K260864

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HGX 2026-06-04

Spectra Platinum Mini

Applicant Uzinmedicare Co., Ltd.

K number K260956

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HGX 2026-05-29

eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)

Applicant Anker Innovations Limited

K number K254300

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HGX 2026-05-21

Wearable Breast Pump (Model S39)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K254244

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HGX 2026-05-13

Electric Breast Pump (HL-3058 II Pro)

Applicant Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K number K254125

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HGX 2026-04-29

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K253914

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HGX 2026-04-22

Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)

Applicant Jiangxi AOV Maternity & Baby Products Co., Ltd.

K number K260239

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HGX 2026-04-10

Freestyle Mini Hands-free

Applicant Medela, LLC

K number K253510

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HGX 2026-04-08

Wearable Breast Pump (Model S21A)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K260033

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HGX 2026-04-08

Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K254258

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HGX 2026-04-07

Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K253946

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HGX 2026-04-06

SPECTRA Wearable 2

Applicant Uzinmedicare Co., Ltd.

K number K250208

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HGX 2026-04-03

Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

Applicant Cixi Ruihong Electric Appliance Co., Ltd.

K number K252744

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HGX 2026-03-12

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

Applicant A Cute Baby, Inc.

K number K252583

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HGX 2026-03-09

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K253934

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HGX 2026-02-13

Motion InBra (YM-8801) wearable breast pump

Applicant Medela, LLC

K number K253149

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HGX 2026-02-13

Wearable Breast Pump (Model W2)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K252422

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HGX 2026-02-13

Wearable Breast Pump (Model W12)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K252420

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HGX 2026-02-06

Spectra S1 Pro; Spectra S2 Pro

Applicant Uzinmedicare Co., Ltd.

K number K251423

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HGX 2026-01-22

Pump In Style® Pro+

Applicant Medela, LLC

K number K253498

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HGX 2025-12-23

Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

Applicant Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.

K number K253072

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HGX 2025-12-19

Wearable Electric Breast Pump (YM-8803)

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K number K252754

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HGX 2025-12-19

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K number K252342

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HGX 2025-11-25

Spectra Platinum

Applicant Uzinmedicare Co., Ltd.

K number K251932

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HGX 2025-10-29

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K253283

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HGX 2025-10-27

Electric Breast Pump (HL-3060, F5113)

Applicant Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K number K252630

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HGX 2025-10-27

Electric Breast Pump (HL-3058, F5112)

Applicant Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K number K252629

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HGX 2025-10-22

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K number K251977

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HGX 2025-09-25

Hi bebe super (BT-150B)

Applicant Bistos Co., Ltd.

K number K251512

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HGX 2025-09-18

Magic InBra

Applicant Medela AG

K number K251377

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HGX 2025-09-08

Wearable Breast Pump (Model S33)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K251754

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HGX 2025-09-08

Momcozy Wearable Breast Pump (BP223)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K251394

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HGX 2025-08-20

Wearable Breast Pump (Model W6)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250383

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HGX 2025-08-13

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K number K252192

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HGX 2025-08-11

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

Applicant Anker Innovations Limited

K number K250207

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HGX 2025-07-31

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250843

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HGX 2025-07-15

Thrive 2-in-1 Breast Pump (Model P3)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250350

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HGX 2025-05-30

Wearable Breast Pump (Model S21)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250368

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HGX 2025-05-30

Motif Aura Glow breast pump (Model Motif Aura Glow)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250365

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HGX 2025-05-30

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K number K242725

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HGX 2025-04-21

Wearable breast pump (model S12A)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K243508

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HGX 2025-04-17

Lacevo Wearable Breast Pump (Model S70)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250829

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HGX 2025-04-02

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250152

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HGX 2025-03-20

Ameda GLO Wearable Breast Pump (Model W8S)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K250463

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HGX 2025-02-21

Wearable breast pump (model W8)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K242850

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HGX 2025-02-06

VIVACE

Applicant Unimom.Co

K number K242111

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HGX 2024-12-20

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

Applicant Shenzhen Root Innovation Technology Co., , Ltd.

K number K243629

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HGX 2024-12-20

Momcozy Wearable Breast Pump (BP311)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K241680

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HGX 2024-12-19

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

Applicant Joytech Healthcare Co. , Ltd.

K number K241322

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HGX 2024-10-17

Electric Breast Pump (F5055)

Applicant Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K number K240218

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HGX 2024-09-27

Elvie Stride 2

Applicant Chiaro Technology, Ltd.

K number K242125

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HGX 2024-09-11

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K number K241004

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HGX 2024-08-30

BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)

Applicant Dongguanshi Yiyingmei Technology Co., Ltd.

K number K231969

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HGX 2024-07-12

MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

Applicant Milkmate Products, Inc.

K number K241705

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HGX 2024-07-01

Wearable Breast Pump (Model S32)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K240536

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HGX 2024-06-27

Annabella Double Breast Pump (ADO-US23-1000)

Applicant Annabella Tech

K number K241506

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HGX 2024-06-06

Wearable Breast Pump,Model S18

Applicant Ningbo Dearevery Electronic Technology Co., Ltd.

K number K232774

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HGX 2024-05-14

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

Applicant Aoj Health Technology Co., Ltd.

K number K233913

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HGX 2024-05-09

Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)

Applicant Jiangxi AOV Maternity & Baby Products Co., Ltd.

K number K232477

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HGX 2024-04-12

Duo Hands-free Breast Pump

Applicant Medela, LLC

K number K232608

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HGX 2024-03-28

VIVACE

Applicant Unimom.Co

K number K232047

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HGX 2024-03-13

Hygeia Express Powered Breast Pump

Applicant Hygeia II Medical Group, Inc.

K number K233136

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HGX 2024-03-06

Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K number K233880

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HGX 2024-01-26

Perifit Pump

Applicant X6 Innovations

K number K231785

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HGX 2024-01-19

Electric Breast Pump, model: YM-8166

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K number K232466

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HGX 2023-11-03

Evenflo Premium Double Electric Breast Pump (Model 4018)

Applicant Evenflo Feeding, Inc.

K number K230481

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HGX 2023-10-26

Electric Breast Pump

Applicant Shenzhen Changkun Technology Co., Ltd.

K number K231595

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HGX 2023-10-16

Willow Generation 3 Breast Pump

Applicant Willow Innovations, Inc.

K number K230570

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HGX 2023-09-21

Smart double sides wearable breast pump, Electric bilateral breast pump

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K number K230102

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HGX 2023-08-04

Annabella Breast Pump

Applicant Annabella , Ltd.

K number K230672

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HGX 2023-07-14

Wearable Breast Pump (Model S18)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K223886

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HGX 2023-06-30

Compact Wearable Pump

Applicant Lansinoh Laboratories

K number K230469

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HGX 2023-06-09

Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K number K230776

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HGX 2023-05-26

Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)

Applicant Guangzhou Yongyi Industrial Co., Ltd.

K number K223329

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HGX 2023-03-30

ARDO Bellis

Applicant Ardo Medical AG

K number K230590

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HGX 2023-03-16

MilkMate Breast Pump

Applicant Milkmate Products, Inc.

K number K223084

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HGX 2023-03-09

Electric breast pump (model: M5)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K number K223693

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HGX 2023-03-03

imani i2Plus Breast Pump

Applicant Imani Co.

K number K222573

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HGX 2023-01-13

Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

Applicant Zhejiang Carebao Co., Ltd.

K number K222782

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HGX 2023-01-04

Wearable Breast Pump (Model S1DW)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K222045

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HGX 2022-12-23

Smartpump 3.0 Double Electric Breast Pump

Applicant Lansinoh Laboratories

K number K222726

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HGX 2022-12-23

CIMILRE Free-T2 Plus

Applicant Cimilre Co., Ltd.

K number K221708

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HGX 2022-12-12

Spectra Wearable

Applicant Uzinmedicare Co., Ltd.

K number K220926

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HGX 2022-12-09

Wearable breast pump

Applicant Mayborn (Uk) Limited

K number K221598

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HGX 2022-10-12

Ameda Pearl Electric Breast Pump

Applicant Ameda, Inc.

K number K221576

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HGX 2022-06-29

Powered Breast Pump (Models 7V and 7X)

Applicant Haenim Co., Ltd.

K number K211016

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HGX 2022-06-27

Wearable Breast Pump (Model S10)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K number K220309

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