Panels › Obstetrics/Gynecology › Product code HGX · Class 2
Pump, Breast, Powered
Regulation 884.5160
39510(k)s in 12 months (255 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 |
|---|---|---|---|
| Sep 25, 1984 | K842766 | CRYSTAL MEDICAL MILK COLLECTION KIT Crystal Medical Products, Inc. | HGX |
| Jun 12, 1981 | K811403 | AXICARE BREAST PUMP MODEL Neonatal Corp. | HGX |
| Jan 28, 1981 | K810065 | SCOTT CM42 PASTEURIZER William Harvey Life Products Corp. | HGX |
| Oct 23, 1980 | K801862 | MEDELA ELECTRIC BREAST PUMP Medela, Inc. | HGX |
| Oct 3, 1980 | K801246 | OXFORD HUMAN MILK PASTEURISER Vickers America Medical Corp. | HGX |
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