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Data / Medical devices / United States / SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)

SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.): FDA-registered device maker in Birmingham, AL, United States, 18 510(k) clearances

SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) is registered with the FDA (registration 1062741) in Birmingham, AL, United States. It lists 19 device types. The FDA files 18 510(k) clearances under its listings, the newest dated January 15, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
FDA registration number
1062741
FEI number
3000302153
Address
801 Tom Martin Dr, Birmingham, AL, United States, 35211
Owner or operator
BAXTER HEALTHCARE CORPORATION (1417572)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
April 1, 1991
Registered through
2026
Brand names listed
Anastomotic Instrument, DermaClose Continous External Tissue Expander, DermaClose XL Continuous External Tissue Expander, Forceps, GEM Biover Clamps, GEM FLOW COUPLER Monitor (GEM2010M-1), GEM Flow COUPLER Monitor Power Cord, GEM Flow Coupler Device and System and more

Devices it lists

DeviceProduct codeClassRoleSource
Applier, Surgical, ClipGDO1Manufacturer, Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Specification developeraccessdata.fda.gov
Clip, ImplantableFZP2Manufacturer, Specification developeraccessdata.fda.gov
Cuff, NerveJXI2Manufacturer, Specification developeraccessdata.fda.gov
Device, Anastomotic, MicrovascularMVR2Manufacturer, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
Flowmeter, Blood, CardiovascularDPW2Manufacturer, Specification developeraccessdata.fda.gov
ForcepsHTD1Manufacturer, Specification developeraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeler, Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyesterGAS2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Specification developeraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufacturer, Specification developeraccessdata.fda.gov
System, Skin ClosureMKY1Manufacturer, Specification developeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 15, 2025K242541GEM ZIPCLIPFZPSubstantially EquivalentSynovis Micro Companies Alliance A Subsidiary of Baxter Intaccessdata.fda.gov
January 28, 2024K233394Gem Flow Now (GEM2770-FN)IYNSubstantially EquivalentSynovis Micro Companies Allianceaccessdata.fda.gov
September 14, 2022K221843GEM Biover Microvascular ClampsDXCSubstantially EquivalentSynovis Micro Companies Alliance, Inc.accessdata.fda.gov
September 6, 2019K190499Gem FlowCoupler SystemMVRSubstantially EquivalentBaxter/ Synovis Micro Companies Alliance, Inc.accessdata.fda.gov
July 9, 2019K191252Gem FlowCoupler SystemMVRSubstantially EquivalentBaxter/ Synovis Micro Companies Alliance, Inc.accessdata.fda.gov
October 28, 2015K152795RiverLon (Nylon) SutureGARSubstantially EquivalentRiverpoint Medicalaccessdata.fda.gov
January 16, 2015K143589GEM Flow COUPLER Device and SystemMVRSubstantially EquivalentSynovis Life Technologies, Inc.accessdata.fda.gov
September 16, 2014K142309GEM Flow COUPLER Device and SystemMVRSubstantially EquivalentSynovis Life Technologies, Inc.accessdata.fda.gov
December 6, 2013K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSGEISubstantially EquivalentOlsen Medicalaccessdata.fda.gov
October 22, 2013K132727GEM FLOW COUPLER DEVICE AND SYSTEMMVRSubstantially EquivalentSynovis Life Technologies, Inc.accessdata.fda.gov
May 23, 2012K111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPGEISubstantially EquivalentOlsen Medicalaccessdata.fda.gov
May 10, 2010K100006HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEEDGATSubstantially EquivalentRiverpoint Medicalaccessdata.fda.gov
February 1, 2010K093310GEM FLOW COUPLER DEVICE AND SYSTEMMVRSubstantially EquivalentSynovis Micro Companies Alliance, Inc.accessdata.fda.gov
October 28, 2008K082870VTI INTRAOPERATIVE DOPPLER SYSTEMSDPWSubstantially EquivalentVascular Technology Incorporatedaccessdata.fda.gov
September 9, 2008K071783VERSAPOD (TM) INSTRUMENT TRAYSKCTSubstantially EquivalentContainmed, Inc.accessdata.fda.gov
March 22, 1999K983007NEUROTUBEJXISubstantially EquivalentNeuroregen, LLCaccessdata.fda.gov
October 13, 1998K981645TITANIUM HEMOSTATIC CLIPFZPSubstantially EquivalentVitalitec Int'L., Inc.accessdata.fda.gov
December 4, 1986K8619853M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)MVRSubstantially Equivalent3M Companyaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 14, 200848974Not yet classifiedTerminatedGEM 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 inCoupler rings may slip out of the delivery toolcaused by jaws larger than specification.accessdata.fda.gov

Compare with other makers

Updated January 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.