Company ยท US
Ameda, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2022. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| 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 |
| 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 |