Panels › General, Plastic Surgery › Product code OOD · Class 2
Surgical Film
Regulation 878.3300
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Tepha, Inc. | 11 | 1 |
| C. R. Bard | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Tepha Incorporated GalaSHAPE 3D; product code SH3D03, a medium size oval
GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where wea Terminated |
OOD | K161092 |
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