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Surgical Film
FDA product code OOD · Class 2 · General, Plastic Surgery
169
Registered devices
1,213
Adverse events
1
Recalls
13
510(k) clearances
Devices with this code
GalaFLEX LITE — Davol Inc.Phasix — Davol Inc.GalaFLEX 3DR — Tepha, Inc.GalaFLEX LITE — Davol Inc.Phasix — Davol Inc.Phasix — Davol Inc.GalaFLEX Scaffold — Tepha, Inc.GalaFLEX 3D — Tepha, Inc.GalaFLEX LITE — Davol Inc.Phasix — Davol Inc.GalaFLEX 3D — Tepha, Inc.GalaSHAPE 3D — Tepha, Inc.GalaSHAPE 3D — Tepha, Inc.Phasix — Davol Inc.GalaSHAPE 3D — Tepha, Inc.TIGR® Matrix Surgical Mesh — Novus Scientific ABGalaFLEX LITE — Davol Inc.Phasix — Davol Inc.GalaFORM 3D — Tepha, Inc.GalaFLEX LITE — Davol Inc.GalaFLEX Scaffold — Tepha, Inc.Phasix — Davol Inc.Phasix — Davol Inc.Phasix — Davol Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-21 | Tepha Incorporated | Endotoxin values from testing of retains slightly exceeded the established specification. |
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