EITAN MEDICAL LTD
FDA Regulatory Profile
EITAN MEDICAL LTD appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0094-2024, Class I) was initiated on September 11, 2023. Its most recent 510(k) clearance was granted on March 10, 2023.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0094-2024 | Class I | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) a | September 11, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213744 | Avoset Infusion Pump System | March 10, 2023 |