Elite Biomedical Solutions LLC
FDA Regulatory Profile
Elite Biomedical Solutions LLC appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2372-2015, Class I) was initiated on June 3, 2015. Its most recent 510(k) clearance was granted on April 29, 2022.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2372-2015 | Class I | Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel | June 3, 2015 |
| Z-2371-2015 | Class I | Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel | June 3, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220695 | Elite Biomedical Solutions Dose Request Cord | April 29, 2022 |