Ameda, Inc.
Buffalo Grove, IL, US
Ameda, Inc. appears in FDA device records in Buffalo Grove, IL. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Ameda, Inc. between 2021 and 2022. The busiest year on record is 2021, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0616-2018 | 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 baby. | Two specific lots was incorrectly manufactured containing a UK power adapter. | Class III | Open, Classified | |
| Z-1327-2015 | 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 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby. | Devices were not sterilized | Class II | Terminated | |
| Z-1326-2015 | 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 device is indicated for assisted expression of milk using manual suction. | Devices were not sterilized | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain