Panels › General, Plastic Surgery › Product code MVR · Class 2
Device, Anastomotic, Microvascular
Regulation 878.4300
0510(k)s in 12 months (9 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in MVR
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 5 |
| Synovis Life Technologies, Inc. | 3 | 0 |
| Synovis Micro Companies Alliance, Inc. | 2 | 1 |
| Baxter/ Synovis Micro Companies Alliance, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| Vioptix, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 2019 | K190499 | Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance, Inc. | MVR |
| Jul 9, 2019 | K191252 | Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance, Inc. | MVR |
| Jan 16, 2015 | K143589 | GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. | MVR |
| Sep 16, 2014 | K142309 | GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. | MVR |
| Oct 22, 2013 | K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Life Technologies, Inc. | MVR |
| Feb 1, 2010 | K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Micro Companies Alliance, Inc. | MVR |
| Apr 17, 2009 | K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM Vioptix, Inc. | MVR |
| Apr 16, 2004 | K040163 | MICROVASCULAR ANASTOMOTIC DEVICE Synovis Micro Companies Alliance, Inc. | MVR |
| Dec 4, 1986 | K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) 3M Company | MVR |
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