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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2024 | K233999 | GalaFLEX LITE Scaffold Tepha, Inc. | OOD |
| Aug 19, 2021 | K202425 | SurgiLattice scaffold Tepha, Inc. | OOD |
| Feb 23, 2017 | K162922 | GalaFORM 3D Tepha, Inc. | OOD |
| Sep 29, 2016 | K161424 | Phasix Mesh C.R. Bard, Inc. | OOD |
| Aug 23, 2016 | K161092 | GalaSHAPE 3D Tepha, Inc. | OOD |
| Mar 31, 2015 | K142818 | Phasix Mesh C. R. Bard | OOD |
| May 21, 2014 | K140533 | GALAFLEX MESH Tepha, Inc. | OOD |
| May 7, 2013 | K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT Tepha, Inc. | OOD |
| Feb 15, 2012 | K113723 | TEPHAFLEX MESH Tepha, Inc. | OOD |
| Feb 15, 2012 | K113721 | TEPHAFLEX LIGHT MESH Tepha, Inc. | OOD |
| Sep 26, 2011 | K111946 | TEPHAFLEX MESH Tepha, Inc. | OOD |
| Aug 7, 2009 | K091633 | TEPHAFLEX SURGICAL FILM Tepha, Inc. | OOD |
| Apr 13, 2007 | K070894 | TEPHAFLEX SURGICAL MESH Tepha, Inc. | OOD |
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