IMPULSE DYNAMICS (USA) INC

FDA Regulatory Profile

IMPULSE DYNAMICS (USA) INC appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1173-2024, Class II) was initiated on January 5, 2024.

Summary

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

Known Names

impulse dynamics (usa), impulse dynamics usa

Recent Recalls

NumberClassProductDate
Z-1173-2024Class IIOPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and LiteJanuary 5, 2024