Company ยท US
Synovis Micro Companies Alliance, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2024 | K233394 | Gem Flow Now (GEM2770-FN) Synovis Micro Companies Alliance | IYN |
| Sep 14, 2022 | K221843 | GEM Biover Microvascular Clamps Synovis Micro Companies Alliance, Inc. | DXC |
| Apr 20, 2022 | K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) Synovis Micro Companies Alliance, Inc. | DPW |
| Feb 1, 2010 | K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Micro Companies Alliance, Inc. | MVR |
| Apr 16, 2004 | K040163 | MICROVASCULAR ANASTOMOTIC DEVICE Synovis Micro Companies Alliance, Inc. | MVR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |