Panels › General, Plastic Surgery › Product code OXE · Class 2
Mesh, Surgical, Collagen, Staple Line Reinforcement
Regulation 878.3300
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OXE
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Biotech Incorporated | 2 | 0 |
| Kerecis Limited | 1 | 0 |
| Synovis Surgical Innovations | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2017 | K170945 | Biodesign Staple Line Reinforcement Cook Biotech Incorporated | OXE |
| Aug 19, 2016 | K153364 | Kerecis SecureMesh Kerecis Limited, IS | OXE |
| Apr 24, 2003 | K030879 | VERITAS COLLAGEN MATRIX Synovis Surgical Innovations | OXE |
| Aug 23, 2002 | K022044 | SURGISIS STAPLE LINE REINFORCEMENT Cook Biotech, Inc. | OXE |
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