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Sign in to claim this brandSYNOVIS MICRO COMPANIES ALLIANCE, INC
US
Last updated May 24, 2026
What SYNOVIS MICRO COMPANIES ALLIANCE, INC makes
The company manufactures single-use surgical bulldog clamps for microvascular procedures, reusable bipolar electrosurgical handpieces and electrodes for open surgery, and reusable vascular anastomosis coupling kits. It also produces bioabsorbable nerve guides made from synthetic polymers, Doppler-equipped vascular couplers, skin-closing tension devices, and reusable sterilization/disinfection containers for medical devices.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) and UDI databases. The company operates from the United States, where its products are subject to U.S. medical device authorization requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- baxter.com
- —
- —
- [email protected]
- Phone
- +1(800)933-0303
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 031284586
Catalogue (76)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GEM Microvascular Anastomotic COUPLER | GEM2753 | FDA UDI | Class II | Active |
| Gem Flow Now | 520002040011 | FDA UDI | Class II | Active |
| Gem Microtray Max | GEM2551-CS | FDA UDI | Class I | Active |
| Gem Microtray | GEM2551-2C | FDA UDI | Class II | Active |
| Gem Microtray | GEM2525 | FDA UDI | Class II | Active |
| Gem Flow Coupler | GEM2755 FC | FDA UDI | Class II | Active |
| GEM BIOVER Microvascular Clamp | TKFV1 | FDA UDI | Class II | Active |
| GEM Microvascular Anastomotic COUPLER | GEM2756 | FDA UDI | Class II | Active |
| Dermaclose | GEM204010-K | FDA UDI | Class I | Active |
| GEM Microvascular Anastomotic COUPLER Sterilization Tray | GEM 2745 | FDA UDI | Class II | Active |
| Dermaclose | GEM204010-K | FDA UDI | Class I | Active |
| GEM COUPLER Double Ended Vessel Measuring Gauge | GEM2749 | FDA UDI | Class I | Active |
| GEM Microvascular Anastomotic COUPLER | GEM2751 I | FDA UDI | Class II | Active |
| GEM Microvascular Anastomotic COUPLER | GEM2752 | FDA UDI | Class II | Active |
| Gem Flow Coupler | GEM2754 FC | FDA UDI | Class II | Active |
| GEM Microvascular Anastomotic COUPLER | GEM2756 I | FDA UDI | Class II | Active |
| GEM Microvascular Anastomotic COUPLER | GEM2755 | FDA UDI | Class II | Active |
| Gem Vessel Everter | GEM2742 | FDA UDI | Class II | Unknown |
| GEM BiPolar Adson Forceps | GEM4050A-NS | FDA UDI | Class II | Active |
| Gem Flow Now (GEM2770-FN) | K233394 | FDA 510(k) | Class II | Active |
| Gem FlowCoupler System | K191252 | FDA 510(k) | Class II | Active |
| GEM Biover Microvascular Clamps | K221843 | FDA 510(k) | Class II | Active |
| Gem Flow Coupler Device And System | K093310 | FDA 510(k) | Class II | Active |
| GEM FLOW COUPLER Monitor (GEM1020M-2) | K213974 | FDA 510(k) | Class II | Active |
| Gem FlowCoupler System | K190499 | FDA 510(k) | Class II | Active |
| Microvascular Anastomotic Device | K040163 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Synovis Micro Companies Alliance, Inc. has one FDA recall record initiated on 2008-05-14, which is listed as terminated. The recall was due to coupler rings potentially slipping out of the delivery tool, attributed to jaws that exceeded the specified size.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 14, 2008 | Z-2138-2008 | — | terminated | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. |