SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.)
Birmingham, AL, US
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) appears in FDA device records in Birmingham, AL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Synovis Micro Companies Alliance, Inc.510(k), recall
510(k) clearance history
FDA records hold 5 510(k) clearances for SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) between 2004 and 2024. The busiest year on record is 2022, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2010 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233394 | Gem Flow Now (GEM2770-FN) | IYN | Substantially Equivalent | |
| K221843 | GEM Biover Microvascular Clamps | DXC | Substantially Equivalent | |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | DPW | Substantially Equivalent | |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | MVR | Substantially Equivalent | |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | MVR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1062741 | 3000302153 | SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | 801 Tom Martin Dr, BIRMINGHAM, AL 35211 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GDOApplier, Surgical, Clip
- DXCClamp, Vascular
- FZPClip, Implantable
- MVRDevice, Anastomotic, Microvascular
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DPWFlowmeter, Blood, Cardiovascular
- HTDForceps
- HPPHeadlamp, Operating, Battery-Operated
- MDMInstrument, Manual, Surgical, General Use
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- MKYSystem, Skin Closure
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2138-2008 | 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 normally encountered in microsurgical vascular reconstructive procedures. | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain