Panels › Obstetrics/Gynecology › Product code HGY · Class 1
Pump, Breast, Non-Powered
Regulation 884.5150
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in HGY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela, Inc. | 3 | 0 |
| Ameda, Inc. | 0 | 2 |
| American Hospital Supply Corp. | 2 | 0 |
| Gerber Products Co. | 2 | 0 |
| Hollister, Inc. | 2 | 0 |
| Avent America, Inc. | 1 | 0 |
| Burditt & Calkins-Siemens-Elema | 1 | 0 |
| Crystal Medical Products, Inc. | 1 | 0 |
| D.J. Colgate Medical, Ltd. | 1 | 0 |
| Eklund & Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2015 | Ameda, Inc. Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8. Terminated |
HGY | K011519 |
| Mar 26, 2015 | Ameda, Inc. Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions).
The Terminated |
HGY | K912355 |
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