Ameda, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0616-2018Class IIIPurely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect theJuly 10, 2017
Z-1327-2015Class IIAmeda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouchFebruary 12, 2015
Z-1326-2015Class IIAmeda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.February 12, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K221576Ameda Pearl Electric Breast PumpOctober 12, 2022
K203570Mya Joy PLUS Breast PumpApril 22, 2021