FDA 510(k) Applications for Medical Device:
Pump, Breast, Powered

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K200712 A Cute Baby, Inc. 865 N 1430 W
Orem UT 84057
K113315 ACUTE IDEAS CO. LTD. 865 N 1430 W
OREM UT 84057
K973501 AMEDA MEDIZINTECHNIK AG 2000 HOLLISTER DR.
LIBERTYVILLE IL 60048
K221576 Ameda, Inc. 485 Half Day Road; Suite 320
Buffalo Grove IL 60089
K203570 Ameda, Inc. 485 Half Day Road; Suite 320
Buffalo Grove IL 60089
K230672 Annabella Ltd. 23/5 Hataas
KFAR SABA 4442525
K241506 Annabella Tech 23/5 Hataas
Kfar Saba 4442525
K233913 AOJ Health Technology Co., Ltd. Rm 302,Block A, Bldg A, Jingfa IntelligentManufacturing Park
Shenzhen 518126
K212773 ARDO Medical AG Gewerbestrasse 19
Unteraegeri 6314
K230590 ARDO Medical AG Gewerbestrasse 19
Unteraegeri 6314
K150721 ARDO MEDICAL AG Gewerbestrasse 19
UNTERAEGERI 6314
K141742 ARDO MEDICAL AG 1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA PA 19103
K172067 Ardo medical AG Gewerbestrasse 19
Unterageri 6314
K051413 AVENT AMERICA, INC. 1 SPEEN STREET
FRAMINGHAM MA 01701
K052047 AVENT AMERICA, INC. 1 SPEEN STREET
FRAMINGHAM MA 01701
K173699 Babyation, LLC 911 Washington Ave
St. Louis MO 63101
K020375 BAILEY MEDICAL ENGINEERING 2216 SUNSET DR.
LOS OSOS CA 93402
K160274 BISTOS CO., LTD. 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302,
Seongnam 13201
K200675 Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302,
Seongnam-si 13201
K100929 BLUE EGG CO 216-5 YONGMOON-DONG, SEO-KU
DAEJON, KOREA
K181863 Chiaro Technology Limited 2nd Floor 63-66 Hatton Garden
London EC1N 8LE
K210936 Chiaro Technology Limited 2nd Floor 63-66 Hatton Garden
London EC1N 8LE
K242125 Chiaro Technology Ltd 63-66 Hatton Garden
London EC1N 8LE
K221708 Cimilre Co., Ltd. 97-14 Seongnam-ro, Mokcheon-Eup, Dongnam-Gu
Cheonan-Si 31234
K162870 CIMILRE CO., LTD. #201, 202, Sagimakgol-ro 148, Jungwon-gu
Seongnam-si 13207
K201903 Cixi Ruihong Electric Appliance Co., Ltd. No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town,
Ningbo 315322
K111411 DAO HEALTH 2526 Capitol Avenue
Sacramento CA 95816
K130349 DAO HEALTH 1345 EASY LN. EL DORADO HILLS
CALIFORNIA CA 95762
K172772 DAO Health 1345 Easy Lane
El Dorado Hills CA 95762
K142168 DEVON MEDICAL PRODUCTS, INC. 1100 FIRST AVENUE, SUITE 202
KING OF PRUSSIA PA 19406
K212884 Dongguan Rongfeng Medical Co., Ltd. Room 201, No. 7 Xiangyuan Road, Shujiu
Dongguan 523570
K231969 Dongguanshi Yiyingmei Technology Co., Ltd. Room 701, No. 31 Tangxi Street Shatou, Chang'an Town
Donguang 523000
K092783 ENKO LTD. 10006 SOKAK, NO.64,
CIGLI - IZMIR 35620
K983776 EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W.
WASHINGTON DC 20036
K960727 EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W.
WASHINGTON DC 20036
K960726 EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W.
WASHINGTON DC 20036
K100435 EVENFLO COMPANY, INC. 225 BYERS RD.
MIAMISBURG OH 45342
K022933 EVENFLO COMPANY, INC. 707 CROSSROADS COURT
VANDALIA OH 45377
K082307 EVENFLO COMPANY, INC. 225 BYERS RD.
MIAMISBURG OH 45342
K052909 EVENFLO COMPANY, INC. 707 CROSSROADS COURT
VANDALIA OH 45377
K102600 EVENFLO COMPANY, INC. 225 BYERS RD.
MIAMISBURG OH 45342
K092770 EVENFLO COMPANY, INC. 225 BYERS RD.
MIAMISBURG OH 45342
K131153 EVENFLO FEEDING INCORPORATED 9277 Centre Pointe Dr Ste 160
West Chester OH 45069
K230481 Evenflo Feeding, Inc. 9277 Centre Pointe Dr.
West Chester OH 45069
K161266 EXPLORAMED NC7, INC 2639A TERMINAL BLVD
MOUNTAIN VIEW CA 94043
K191577 Exploramed NC7, Inc. 1975 W. El Camino Real, Suite 306
Mountain View CA 94040
K240218 Fimilla (Shanghai) maternity & baby Articles Co., Ltd No. 65 Lane 3029 HuaXu Road HuaXin Town QingPu District
Shanghai
K102516 GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE
GREAT NECK NY 11021
K112856 GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE
HICKSVILLE NY 11801
K143574 Genadyne Biotechnologies, Inc. 16 Midland Ave
Hicksville NY 11801
K043098 GERBER PRODUCTS CO. 445 STATE ST.
FREMONT MI 49413
K172842 Globalcare No7 factory European Ind. Park
Xiaolan Town, Zhongshan City 528415
K193449 Guangdong Horigen Mother & Baby Products Co., Ltd No. 18, Pingnan Industrial Zone, Mianbei Street,
Shantou 515100
K201152 Guangdong Horigen Mother & Baby Products Co., Ltd. Block A&B&C, NCBC Industrial Park, 6th Baolong Road,
Shantou 515100
K212564 Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street
Shantou 515100
K182413 Guangdong Horigen Mother & Baby Products Co., Ltd. No.8, Yi Road, Pingbei Industrial Zone, Chaoyang District
Shantou 515100
K162747 Guangdong Horigen Mother & Baby Products Co., Ltd. NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District
Shantou 515100
K232466 Guangdong Youmeng Electrical Technology Co., Ltd. One of Area A, level 3, Building 2, No. 17, Keyuan 3rd Road
Foshan 528303
K150923 Guangzhou Jinxinbao Electronic Co.,Ltd No.38 Huanzhen Xi Road,
Guangzhou,Guangdong 511470
K223329 Guangzhou Yongyi Industrial Co., Ltd. No. 4, Majun Rd., Dongchong Town, Nansha District
Guangzhou 523000
K192640 Guangzhou Yongyi Industrial Co., Ltd. B3, No. 29, Qixin Road, Dongchong Town, Nansha District
Guangzhou 511400
K211016 Haenim Co., Ltd. 15, Saryeom-ro 21beon-gil, Seo-gu
Incheon 22742
K230102 Huizhou LVB Maternal And Infant Supplies Co,Ltd. Block A 16 Huifengxi 3rd,Pingnan Industry Zone, Zhongkai
Huizhou 516000
K241004 HuiZhou LVB Maternal and Infant Supplies Co., Ltd. NO. 114,Xin Xing North Road, Sandong Town, Huicheng District
Huizhou 516000
K190465 Hygeia II Medical Group, Inc. 6241 Yarrow Drive
Carlsbad CA 92011
K200406 Hygeia II Medical Group, Inc. 6241 Yarrow Drive
Carlsbad CA 92011
K212955 Hygeia II Medical Group, Inc. 6241 Yarrow Drive
Carlsbad CA 92011
K233136 Hygeia II Medical Group, Inc. 6241 Yarrow Drive
Carlsbad CA 92011
K081932 HYGEIA MEDICAL, INC. 6353 CORTE DEL ABETO
CARLSBAD CA 92011
K202045 imani Co. 1F, Na Dong, 19, Wanjangcheon-ro 394beon-gil, Namsa-myeon,
Yongin-si 17117
K202037 imani Co. 1F, Na Dong, 19, Wanjangcheon-ro 394beon-gil, Namsa-myeon,
Yongin-si 17117
K222573 imani Co. 147, Hwasan-ro, Idong-eup, Cheoin-gu
Yongin-si 17135
K232477 Jiangxi AOV Maternity & Baby Products Co., Ltd. 8. Nanhuan Road, Industrial Park
Guixi 335400
K172989 Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone
Hangzhou 311100
K241322 Joytech Healthcare Co., Ltd. No.365, Wuzhou Road
Hangzhou 311100
K971543 KAWECO GMBH 55 NORTHERN BLVD., SUITE 410
GREAT NECK NY 11021
K981549 LACTATION TECHNIQUES, INC. 1252 WEST 50 SOUTH
SALT LAKE CITY UT 84014
K230469 Lansinoh Laboratories 99 Canal Center Plaza, Suite 550
Alexandria VA 22314
K222726 Lansinoh Laboratories 99 Canal Center Plaza, Suite 550
Alexandria VA 22314
K122474 LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN 13417 QUIVAS ST
WESTMINSTER CO 80234
K182749 Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd Sti.
Cigli 35620
K082802 LEARNING CURVE BRANDS INC. THE FIRST YEARS 100 TECHNOLOGY CTR. DR.
STOUGHTON MA 02072
K051926 LIMERICK, INC. 1313-23RD ROAD
KANOPOLIS KS 67454
K021739 LIMERICK, INC. 903 NORTH SAN FERNANDO BLVD.
BURBANK CA 91504
K012275 LIMERICK, INC. 903 NORTH SAN FERNANDO BLVD.
BURBANK CA 91504
K132220 LIMERICK, INC. 2150 N. GLENOAKS BLVD.
BURBANK CA 91504
K100385 LUV N' CARE, LTD. 1705. S CAPITOL OF TEXAS HWY
AUSTIN TX 78746
K101157 MAPA GMBH 2081 LONGDEN CIRCLE
LOS ALTOS CA 94024
K121478 MAPA GMBH 728 BOOSTER BLVD.
REEDSBURG WI 53959
K221598 Mayborn (UK) Limited Mayborn House Balliol Business Park,
Newcastle Upon Tyne, NE12 8EW
K110343 MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD NORTHUMBERLAND BUSINESS PARK W
CRAMLINGTON, NORTHUMBERLAND NE23 7RH
K121322 MAYBORN GROUP LIMITED DUDLEY LANE
NORTHUMBERLAN NE23 TRH
K113664 MAYBORN GROUP LIMITED DUDLEY LANE
NORTHUMBERLAN NE23 TRH
K081463 MEDEL S.P.A. 112 CAVISTION WAY
CARY NC 27519
K150499 MEDELA AG LATTICHSTRASSE 4B
BAAR 6341
K191653 Medela AG Laettichstrasse 4b
Baar Zug CH-6341
K053052 MEDELA AG LAETTICHSTRASSE 4B
BAAR, ZUG CH-6341
K151632 MEDELA AG LATTICHSTRASSE 4B
BAAR 6341
K232608 Medela LLC 1101 Corporate Drive
McHenry IL 60050
K200508 Medela LLC 1101 Corporate Drive
McHenry IL 60050
K181937 Medela LLC 1101 Corporate Drive
McHenry IL 60050
K210759 Medela LLC 1101 Corporate Drive
McHenry IL 60050
K161725 MEDELA, INC 1101 CORPORATE DRIVE
MCHENRY IL 60050
K031614 MEDELA, INC. 1101 CORPORATE DR.
MCHENRY IL 60050-7005
K020518 MEDELA, INC. LAETTICHSTRASSE 4B
BAAR, ZUG, 6341
K241705 MilkMate Products Inc. 780 3rd Avenue
New York NY 10017
K223084 MilkMate Products, Inc. 41 Purdy Ave, Box #1052
Rye NY 10580
K170722 Moxxly, Inc. 1777 Yosemite Ave. Suite 235
San Francisco CA 94124
K163183 Nantong Poly Technology Co., Ltd. No.332, Xinxing Road, Development Zone
Nantong 226010
K952712 NATURAL TECHNOLOGIES, INC. 924 C CALLE NEGOCIO
SAN CLEMENTE CA 92673
K160511 NAYA HEALTH INC. 390 BRIDGE PKWY
Redwood City CA 94065
K232774 Ningbo Dearevery Electronic Technology Co., LTD No3-1, Gongji South Road, Hudi Village, Linshan Town
Yuyao 315460
K191802 Ningbo Huiyoo Baby Products Co. Ltd. 523# Cizhang Road, Zhangqi Industrial Area
Cixi 315313
K203148 Ningbo Youhe Electrical Appliance Technology Co., Ltd. No.567, Xintang Road, Fuhai Town
Cixi 315322
K163136 NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. NO.226-228, SAN JIAO TIAN RD, FU HAI TOWN
CIXI 315322
K242725 Ningbo Youhe Electrical Appliance Technology Co.,Ltd. No.567,Xintang Road,Fuhai Town
Cixi 315322
K203383 Philips Consumer Lifestyle - Innovation Site Eindhoven High Tech Campus 37
Eindhoven 5656 AE
K201381 Philips Consumer Lifestyle - Innovation Site Eindhoven High Tech Campus 37
Eindhoven 5656 AE
K161532 Philips Consumer Lifestyle-Innovation Site Eindhoven High Tech Campus 37
Eindhoven 5656 AE
K022594 PLAYTEX PRODUCTS, INC. 75 COMMERCE DR.
ALLENDALE NJ 07401-1600
K061013 PLAYTEX PRODUCTS, INC. 75 COMMERCE DR.
ALLENDALE NJ 07401-1600
K211024 Shantou Huihengqi Electronic Technology Co., Ltd. 501, 5/F, Block C, 14A Industrial Zone, Longhu District
Shantou 515000
K132882 SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD 7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD
GUANGZHOU, GUANGDONG 510420
K143585 SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD NO.8, YI ROAD, PINGBEI INDUSTRIAL ZONE
SHANTOU, GUANGDONG 515100
K231595 Shenzhen Changkun Technology Co., Ltd. Room 501, Changkun Technology Building A, 12 Shijia Road
Shenzhen 518118
K223693 Shenzhen Lutejiacheng Technology Co., Ltd. #2-201, Floor 2 Hasee Computer Building, No.2 Beier Rd,
Shenzhen 518129
K230776 Shenzhen Lutejiacheng Technology Co., Ltd. #2-2, Floor 2 Hasee Computer Building, No.2 Beier Rd,
Shenzhen 518129
K220309 Shenzhen Lutejiacheng Technology Co., Ltd. Rm 903 Jiangnan BLDG, No.l Bantian Ave. South, Ma'antang
Shenzhen
K233880 Shenzhen Root Innovation Technology Co., Ltd. #2-201, Floor 2 Hasee Computer Building, No.2 Beier Rd,
Shenzhen 518129
K241680 Shenzhen Root Innovation Technology Co., Ltd. #2-201, Floor 2, Hasee Computer Building, No. 2 Beier Rd.
Shenzhen 518129
K250463 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building,
Shenzhen 518100
K250152 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building,
Shenzhen 518100
K250829 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor,29th Building, Lianchuang Technology
Shenzhen 518100
K250365 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building, Lianchuang Technology Pa
Shenzhen 518100
K250350 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building,
Shenzhen 518100
K212180 Shenzhen TPH Technology Co., Ltd. Bulan Road, Nanwan Community, Longgang District
Shenzhen 518100
K243508 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building, Lianchuang Technology
Shenzhen 518100
K223886 Shenzhen TPH Technology Co., Ltd. 5th floor,Lianchuang 2nd technology Park, Bulan Road
Shenzhen 518100
K250368 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building, Lianchuang Technology
Shenzhen 518100
K240536 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor,29th Building, Lianchuang Technology
Shenzhen 518100
K220596 Shenzhen TPH Technology Co., Ltd. 5th floor, Lianchuang 2nd technology Park,
Shenzhen 518100
K242850 Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor,29th Building,Lianchuang Technology Park
Shenzhen 518100
K222045 Shenzhen TPH Technology Co.,Ltd. 5th floor, Building NO.29 Eastside
Shenzhen 518100
K243629 ShenzhenáRootáInnovationáTechnologyáCo.,áLtd. #2-201, Floor 2, Hasee Computer Building,
Shenzhen 518129
K093648 SIMPLISSE INC. 1340 WEST PENNSYLVANIA AVE
SAN DIEGO CA 92103
K032566 THE FIRST YEARS, INC. ONE KIDDIE DR.
AVON MA 02322
K033131 THE FIRST YEARS, INC. ONE KIDDIE DR.
AVON MA 02322
K964403 THE FIRST YEARS, INC. ONE KIDDIE DR.
AVON MA 02322
K964396 THE NATURAL CHOICE CO., INC. 1155 CHESS DRIVE, SUITE 115
FOSTER CITY CA 94404
K131027 TOMY INTERNATIONAL 45 SHAWMUT ROAD
CANTON MA 02021
K180075 Unimom Co. 110-19 Gajangsaneopseobuk-ro
Osan-si 18102
K190810 Unimom Co. 110-19, Gajangsaneopseobuk-ro
Osan-si 18102
K232047 Unimom.Co 110-19, Gajangsaneopseobuk-ro
Osan-si 18102
K242111 Unimom.Co 110-19, Gajangsaneopseobuk-ro
Osan-si 18102
K191208 Uzinmedicare Co. 56, Dongtansandan 5-Gil, Dongtan-Myeon
Hwaseong-Si 18487
K191109 Uzinmedicare Co. Rm 105, Joongang Induspia V, Sagimakgolo 137,
Seongnam-si 13202
K150476 UZINMEDICARE CO. Rm 105, Joongang Induspia V, Sagimakgolo 137
Jungwon-gu 462-807
K181784 Uzinmedicare Co. 56, Dongtansandan 5-Gil, Dongtan-Myeon
Hwaseong-Si 18487
K093145 UZINMEDICARE CO. 503 -2 CHANG-RI, NAMSA -MYEON
YONGIN 449-885
K210124 Uzinmedicare Co. 56, Dongtansandan 5-Gil,Dongtan-Myeon
Hwaseong-Si 18487
K220926 Uzinmedicare Co., Ltd. 56, Dongtansandan 5-Gil
Hwaseong-Si 18487
K162415 Uzinmedicare Company Room 105, Joongang Induspia V, Sagimakgolo 137
Seoul 13202
K022140 WHISPER WEAR 19526 EAST LAKE DR.
MIAMI FL 33015
K970488 WHITE RIVER CONCEPTS 924 C CALLE NEGOCIO
SAN CLEMENTE CA 92673
K964679 WHITE RIVER CONCEPTS 924 C CALLE NEGOCIO
SAN CLEMENTE CA 92673
K070435 WHITTLESTONE, INC. 102 HERITAGE AVE
CASTLE ROCK CO 80104-y
K002696 WHITTLESTONE, INC. 601A STONE RD.
BENICIA CA 94510
K051112 WHITTLESTONE, INC. 602 B STONE RD.
BENICIA CA 94510
K213311 Willow Innovations, Inc. 1975 W. El Camino Real, Suite 306
Mountain View CA 94040
K230570 Willow Innovations, Inc. 1975 W. El Camino Real, Suite 306
Mountain View CA 94040
K142479 WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT
WUXI CITY 214000
K202802 Wuxi Xinzhongrui Baby Supplies Co., Ltd. No. 117 Xinhua Road, Meicun, New Wu District,
Wuxi 214000
K151284 Wuxi Xinzhongrui Baby Supplies Co.,Ltd NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT
WUXI 214115
K231785 X6 Innovations 128 Rue La BoΘtie
Paris 75008
K211755 Zhejiang Carebao Co., Ltd. 3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone
Ningbo 315000
K222782 Zhejiang Carebao Co., Ltd. 3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone,
Ningbo 325400




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact