Panels › Cardiovascular › Product code OMR · Class 2
Vessel Guard Or Cover
Regulation 870.3470
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OMR
| Company | 510(k)s | Recalls |
|---|---|---|
| Mimedx Group, Inc. | 4 | 0 |
| Spinemedica, LLC | 2 | 0 |
| Synthes Spine | 2 | 0 |
| Replication Medical, Inc. | 1 | 0 |
| Xylos Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2012 | K111048 | SYNTHES SCOUT TACK FIXATION Synthes Spine | OMR |
| May 20, 2011 | K111137 | HYDROFIX VASO SHIELD Mimedx Group, Inc. | OMR |
| Apr 8, 2011 | K101805 | HYDROFIX VASO SHIELD Mimedx Group, Inc. | OMR |
| Feb 18, 2011 | K103558 | SYNTHES SCOUT VESSEL GUARD Synthes Spine | OMR |
| Jul 28, 2010 | K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 Mimedx Group, Inc. | OMR |
| Jul 7, 2010 | K100984 | XYLOS VESSEL GUARD Xylos Corporation | OMR |
| Jun 2, 2010 | K100905 | HYDROFIX SURGICAL SHEET Mimedx Group, Inc. | OMR |
| Dec 24, 2009 | K093551 | PARADIS VASO SHIELD Spinemedica, LLC | OMR |
| Apr 20, 2009 | K090022 | PARADIS VASO SHIELD Spinemedica, LLC | OMR |
| Apr 2, 2009 | K082782 | REPLICATION MEDICAL VESSEL GUARD Replication Medical, Inc. | OMR |
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