Powers Medical Devices, LLC

FDA Regulatory Profile

Powers Medical Devices, LLC appears in FDA public data with 1 recall, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0395-2016, Class II) was initiated on October 1, 2015.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0395-2016Class IIThe "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player October 1, 2015