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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2020 | Baxter Healthcare Corporation FLOW COUPLER Monitor
Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm).
Implantable device for vascular use. Open, Classified |
MVR | K191252 |
| Jun 2, 2020 | Baxter Healthcare Corporation Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Open, Classified |
MVR | K191252 |
| Mar 5, 2020 | Baxter Healthcare Corporation GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system. Terminated |
MVR | K861985 |
| Mar 5, 2020 | Baxter Healthcare Corporation GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral va Terminated |
MVR | K861985 |
| Mar 5, 2020 | Baxter Healthcare Corporation GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral v Terminated |
MVR | K861985 |
| Aug 2, 2008 | Synovis Micro Companies Alliance Inc GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized
This is a microsurgical coupler used in the anastomosis of veins and arteries no Terminated |
MVR | K040163 |
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