Aaren Scientific Inc.
FDA Regulatory Profile
Aaren Scientific Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0071-2018, Class II) was initiated on September 1, 2017. Its most recent 510(k) clearance was granted on April 15, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0071-2018 | Class II | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. | September 1, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | April 15, 2013 |