Restoration Robotics
Restoration Robotics appears in FDA public data with 4 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0353-2014, Class II) was initiated on October 13, 2013. Its most recent 510(k) clearance was granted on March 16, 2018.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0353-2014 | Class II | Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; | October 13, 2013 |
| Z-0354-2014 | Class II | ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dis | October 13, 2013 |
| Z-0355-2014 | Class II | Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; N | October 13, 2013 |
| Z-0356-2014 | Class II | ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum T | October 13, 2013 |