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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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SYNERGY MATRIX SOFTWARE LICENSE
ARTHREX, INC.
AR-3200-1052
In Commercial Distribution

  • 00888867339941 ()
AR-3200-1052

  • Multidisciplinary medical image management software
Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
Not in Commercial Distribution

  • B562C2C20210 ()


  • External orthopaedic fixation frame calculation software
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11100-005-50
In Commercial Distribution

  • 00817655022642 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
SOFTWARE E-SCRIBE WORKSTATION V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020686 ()
11012-016-51

  • Patient health record information system application software
SOFTWARE E-SCRIBE SERVER V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020679 ()
11012-016-50

  • Patient health record information system application software
Reflux software v6.1 upgrade
Given Imaging, Inc.
FGS-0657
In Commercial Distribution

  • 07290110360436 ()


  • Gastrointestinal telemetric monitoring system
AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump
Cardiac PET Processing Software
Bracco Diagnostics Inc.
1.00
In Commercial Distribution

  • 30815112020584 ()
001771

  • Image segmentation application software
FLUOROSCOPY SOFTWARE 2.3 - ENABLE
Stryker Leibinger GmbH & Co. KG
6004-650-300
In Commercial Distribution

  • 07613154637164 ()
6004-650-300

  • Robotic surgical navigation system application software
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