AMEDA, INC.
AMEDA, INC. appears in FDA public data with 3 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0616-2018, Class III) was initiated on July 10, 2017. Its most recent 510(k) clearance was granted on October 12, 2022.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0616-2018 | Class III | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the | July 10, 2017 |
| Z-1327-2015 | Class II | Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouch | February 12, 2015 |
| Z-1326-2015 | Class II | Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9. | February 12, 2015 |