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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | AMEDA, INC. Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA.
Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a Open, Classified |
HGX | K973501 |
| Apr 4, 2014 | Energizer Personal Care Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package. Terminated |
HGX | K061013 |
| Feb 11, 2011 | Medela Inc Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 6005 Terminated |
HGX | K031614 |
| Sep 24, 2010 | Medela Inc Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breas Terminated |
HGX | K875300 |
| Sep 24, 2010 | Medela Inc Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, a Terminated |
HGX | K801862 K823840 +1 |
| Sep 24, 2010 | Medela Inc Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's Terminated |
HGX | K020518 K875300 |
| Sep 24, 2010 | Medela Inc Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk Terminated |
HGX | K020518 |
| Apr 27, 2010 | Medela Inc Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user Terminated |
HGX | K020518 |
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