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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.9
In Commercial Distribution

  • 20085412676610 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump
Reflux software v6.1 upgrade
Given Imaging, Inc.
FGS-0657
In Commercial Distribution

  • 07290110360436 ()


  • Gastrointestinal telemetric monitoring system
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system
PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software
SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software
MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software
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