Tepha, Inc.
FDA 510(k) & PMA Approved Devices — 16 products
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Total Devices16
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K233999 | GalaFLEX LITE Scaffold | OOD | 2024-04-09 | View |
| 510(k) | K202425 | SurgiLattice scaffold | OOD | 2021-08-19 | View |
| 510(k) | K211307 | GalaSTITCH Absorbable Monofilament Suture | NWJ | 2021-05-27 | View |
| 510(k) | K162922 | GalaFORM 3D | OOD | 2017-02-23 | View |
| 510(k) | K161092 | GalaSHAPE 3D | OOD | 2016-08-23 | View |
| 510(k) | K132348 | TEPHAFLEX BRAIDED SUTURE | NWJ | 2013-09-05 | View |
| 510(k) | K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | OOD | 2013-05-07 | View |
| 510(k) | K113721 | TEPHAFLEX LIGHT MESH | OOD | 2012-02-15 | View |
| 510(k) | K113723 | TEPHAFLEX MESH | OOD | 2012-02-15 | View |
| 510(k) | K111946 | TEPHAFLEX MESH | OOD | 2011-09-26 | View |
| 510(k) | K101287 | TEPHAFLEX COMPOSITE MESH | OWT | 2010-08-30 | View |
| 510(k) | K091633 | TEPHAFLEX SURGICAL FILM | OOD | 2009-08-07 | View |
| 510(k) | K082178 | TEPHAFLEX ABSORBABLE SUTURE | NWJ | 2008-10-30 | View |
| 510(k) | K081099 | TEPHAFLEX ABSORBABLE SUTURE | NWJ | 2008-07-15 | View |
| 510(k) | K072520 | TEPHAFLEX SURGICAL FILM | FTL | 2007-11-29 | View |
| 510(k) | K070894 | TEPHAFLEX SURGICAL MESH | OOD | 2007-04-13 | View |
No matching devices.
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