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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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M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder
M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder
CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software
CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851659 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software
CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software
AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump
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
SYNERGY MATRIX SOFTWARE LICENSE
ARTHREX, INC.
AR-3200-1052
In Commercial Distribution

  • 00888867339941 ()
AR-3200-1052

  • Multidisciplinary medical image management software
Spine Guidance 5 Software
Stryker Leibinger GmbH & Co. KG
6002-810-000
In Commercial Distribution

  • 07613327616118 ()
6002-810-000

  • Optical surgical navigation device tracking system
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