Abeon Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0686-2016 | Class II | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE | November 25, 2015 |
| Z-0685-2016 | Class II | TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue re | November 25, 2015 |
| Z-0684-2016 | Class II | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. | November 25, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142467 | IntelAir Nasal Airway Support System | November 24, 2014 |
| K131506 | AIRWAY SUPPORT SYSTEM / AIRPORT | March 6, 2014 |