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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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Radiotherapy quality assurance software tool.
DOSISOFT
2.0.10
In Commercial Distribution

  • B501EPIGRAY020010 ()
EP1001

  • Radiation therapy software
Radiotherapy software quality assurance tool
DOSISOFT
2.0.7
In Commercial Distribution

  • B501EPIGRAY020007 ()
2.0.7

  • Radiation therapy software
Radiotherapy software quality assurance tool.
DOSISOFT
2.0.6
In Commercial Distribution

  • B501EPIGRAY020006 ()
2.0.6

  • Radiation therapy software
Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution

  • B557ECHOINSIGHT0 ()


  • Cardiac mapping system application software
Synergy Matrix Core Software License
ARTHREX, INC.
AR-3200-1053
In Commercial Distribution

  • 00888867384866 ()
AR-3200-1053

  • Multidisciplinary medical image management software
Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
ImageFusion 3 Software Install Kit
INTEGRA LIFESCIENCES CORPORATION
IF3000
Not in Commercial Distribution

  • M433IF30001 ()
  • 10381780252634 ()


  • Stereotactic radiosurgical invasive head frame
NeuroSight Arc Software on Laptop
INTEGRA LIFESCIENCES CORPORATION
ST1000
Not in Commercial Distribution

  • M433ST10001 ()
  • 10381780252627 ()
ST1000

  • Neurological stereotactic surgery system
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