EITAN MEDICAL LTD

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0094-2024Class ISapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) aSeptember 11, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K213744Avoset Infusion Pump SystemMarch 10, 2023