SUREPULSE MEDICAL LTD

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1357-2026Class IIISurepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorJanuary 20, 2023
Z-1356-2026Class IIISurepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorJanuary 20, 2023
Z-1360-2026Class IIISurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorJanuary 20, 2023
Z-1358-2026Class IIISurepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorJanuary 20, 2023
Z-1359-2026Class IIISurepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorJanuary 20, 2023