Elana, Inc.
Elana, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0698-2017, Class II) was initiated on November 9, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0698-2017 | Class II | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride | November 9, 2016 |
| Z-1143-2013 | Class II | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess | February 14, 2013 |