Company ยท US
Synovis Surgical Innovations
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2013. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2013 | K122306 | SYNOVIS COLLAGEN MATRIX (TBD) Synovis Surgical Innovations | DXZ |
| Nov 26, 2008 | K083039 | VERITAS COLLAGEN MATRIX (DRY) Synovis Surgical Innovations | FTM |
| Dec 6, 2006 | K062915 | VERITAS COLLAGEN MATRIX Synovis Surgical Innovations | FTM |
| Oct 27, 2004 | K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD Synovis Surgical Innovations | FTM |
| Apr 14, 2004 | K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT Synovis Surgical Innovations | DXZ |
| Mar 17, 2004 | K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION Synovis Surgical Innovations | FTM |
| Mar 9, 2004 | K040001 | STEERABLE STYLET Synovis Surgical Innovations | DRB |
| Apr 24, 2003 | K030879 | VERITAS COLLAGEN MATRIX Synovis Surgical Innovations | OXE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2015 | Synovis Surgical Innovations, Inc. Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product cod Terminated |
DXZ | K142461 |
| Nov 18, 2013 | Synovis Surgical Innovations, Inc. Dura Guard, Dural Repair Patch with Apex Processing.
For use as a dura substitute for the closure of dura mater during neurosurgery.
Product Code:
DG0209SN
DG0209SN
DG0209SN
DG0209SN
DG02 Terminated |
GXQ | K982282 |
| Nov 18, 2013 | Synovis Surgical Innovations, Inc. Vascu Guard, Peripheral Vascular Patch with Apex Processing.
For use in peripheral vascular reconstruction.
Product Code:
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
V Terminated |
DXZ | K983602 |