MAST Biosurgery USA, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1076-2015 | Class II | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 | August 26, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K090637 | CARDIO-WRAP | January 7, 2010 |
| K063648 | SURGI-WRAP MAST TENDON SHEET | March 7, 2007 |
| K061473 | SURGI-WRAP MAST BIORESORBABLE SHEET | September 21, 2006 |
| K050332 | SURGI-WRAP MAST BIORESORBABLE SHEET | May 27, 2005 |