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)
Top companies in HGX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 19 | 6 |
| Shenzhen TPH Technology Co., Ltd. | 24 | 0 |
| Uzinmedicare Co. | 12 | 0 |
| Shenzhen Root Innovation Technology Co., Ltd. | 11 | 0 |
| Evenflo Co., Inc. | 9 | 0 |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | 6 | 0 |
| Ardo Medical AG | 5 | 0 |
| Crystal Medical Products, Inc. | 4 | 0 |
| Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 4 | 0 |
| Guangdong Youmeng Electrical Technology Co., Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 7, 2017 | K162870 | CIMLRE F1 and CIMILRE S3 Cimilre Co., Ltd., KR | HGX |
| Dec 8, 2016 | K162747 | Proture Double Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| Oct 28, 2016 | K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Sili Medela, Inc. | HGX |
| Sep 1, 2016 | K160274 | Hi bebe plus Bistos Co., Ltd., KR | HGX |
| Aug 29, 2016 | K161532 | Philips Avent Comfort Single/Twin Electric Breast Pump Philips Consumer Lifestyle - Innovation Site Eindhoven, NL | HGX |
| Aug 11, 2016 | K161266 | Athena Breast Pump Exploramed Nc7, Inc. | HGX |
| Jun 24, 2016 | K160511 | Naya Breast Pump System Naya Health, Inc. | HGX |
| Apr 15, 2016 | K150476 | Spectra S1Plus and Spectra S2 Plus Uzinmedicare Co., KR | HGX |
| Dec 21, 2015 | K151284 | Electric Double Breast Pumps Wuxi Xinzhongrui Baby Supplies Co., Ltd., CN | HGX |
| Nov 6, 2015 | K150923 | Breast Pump Guangzhou Jinxinbao Electronic Co., Ltd., CN | HGX |
| Nov 5, 2015 | K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), S Medela AG, CH | HGX |
| Jun 17, 2015 | K150721 | ARDO Calypso Pro Powered Breast Pump Ardo Medical AG, CH | HGX |
| May 6, 2015 | K143585 | Electric Breast Pump Shantou Xinghe Electrical Apparatuses Co., Ltd., CN | HGX |
| Apr 21, 2015 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty Medela AG, CH | HGX |
| Apr 21, 2015 | K143574 | Melodi Prime Breast Pump Genadyne Biotechnologies, Inc. | HGX |
| Feb 24, 2015 | K142479 | MEGNA BREAST PUMPS Wuxi Xinzhongrui Baby Supplies Co., Ltd., CN | HGX |
| Feb 20, 2015 | K132220 | PJ'S SERENITY Limerick, Inc. | HGX |
| Dec 4, 2014 | K142168 | NATURE'S BOND 600 AND NATURE'S BOND 603 Devon Medical Products, Inc. | HGX |
| Oct 17, 2014 | K141742 | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS Ardo Medical AG | HGX |
| Apr 24, 2014 | K132882 | ELECTRIC BREAST PUMP Shantou Xinghe Electrical Apparatuses Co., Ltd., CN | HGX |
| Sep 6, 2013 | K130349 | FREEMIE BREAST COLLECTION SYSTEM Dao Health | HGX |
| Jun 18, 2013 | K131153 | EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP Evenflo Feeding Incorporated | HGX |
| May 30, 2013 | K131027 | MEMORY PUMP MODEL Y4947 Tomy International | HGX |
| Apr 5, 2013 | K121478 | NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP Mapa GmbH | HGX |
| Dec 28, 2012 | K122474 | LANSINOH POWERED ELECTRIC BREAST PUMP Lansinoh Laboratories Saglik Gerecleri Tasarim San | HGX |
| Nov 20, 2012 | K113315 | RUMBLE TUFF Acute Ideas Co. , Ltd. | HGX |
| May 31, 2012 | K121322 | CLOSER TO NATURE Mayborn Group Limited, GB | HGX |
| May 10, 2012 | K112856 | LUCINA-MELODI Genadyne Biotechnologies, Inc. | HGX |
| Feb 17, 2012 | K113664 | CLOSER TO NATURE ELECTRIC BREAST PUMP Mayborn Group Limited, GB | HGX |
| Feb 1, 2012 | K111411 | FREEMIE (R) Dao Health | HGX |
| Aug 11, 2011 | K102516 | LUCINA MODEL MELODI Genadyne Biotechnologies, Inc. | HGX |
| Mar 11, 2011 | K110343 | TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP Mayborn Baby and Child / Jackel International, Ltd., GB | HGX |
| Dec 22, 2010 | K102600 | SIMPLYGO BREAST PUMP Evenflo Company, Inc. | HGX |
| Sep 17, 2010 | K101157 | E-BASIC SINGLE BREAST PUMP Mapa GmbH | HGX |
| Aug 13, 2010 | K093145 | SPECTRA SERIES BREAST PUMP Uzinmedicare Co., KR | HGX |
| Jul 14, 2010 | K093648 | SIMPLISSE ELECTRIC BREASTFEEDING COMPANION Simplisse, Inc. | HGX |
| Jun 16, 2010 | K100929 | UNIMOM ALLEGRO Blue Egg CO, KR | HGX |
| May 28, 2010 | K100435 | AMEDA PLATINUM BREAST PUMP Evenflo Company, Inc. | HGX |
| Mar 24, 2010 | K100385 | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP Luv N' Care, Ltd. | HGX |
| Oct 22, 2009 | K092783 | DEBP Enko , Ltd., TR | HGX |
| Oct 9, 2009 | K092770 | SIMPLYGO HANDS FREE BREAST PUMP Evenflo Company, Inc. | HGX |
| Feb 6, 2009 | K081463 | MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP Medel S.P.A. | HGX |
| Jan 22, 2009 | K081932 | ENDEARE BREAST PUMP Hygeia Medical, Inc. | HGX |
| Oct 9, 2008 | K082802 | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B Learning Curve Brands Inc. the First Years | HGX |
| Sep 11, 2008 | K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT Evenflo Company, Inc. | HGX |
| Jul 17, 2007 | K070435 | DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 Whittlestone, Inc. | HGX |
| Aug 15, 2006 | K061013 | PLAYTEX EMBRACE PETITE BREAST PUMP Playtex Products, Inc. | HGX |
| May 2, 2006 | K053052 | MEDELA SWING BREAST PUMP Medela AG, CH | HGX |
| Dec 12, 2005 | K051926 | LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP Limerick, Inc. | HGX |
| Nov 1, 2005 | K052909 | EVENFLO ELAN BREAST PUMP Evenflo Company, Inc. | HGX |
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