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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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No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300367 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300299 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300237 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300176 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300152 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300145 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300084 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300077 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.0
In Commercial Distribution

  • 08800025300039 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300022 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.0
In Commercial Distribution

  • 08800025300015 ()


  • Radiological PACS software
No Description
GE HEALTHCARE
2.0 SP 14
In Commercial Distribution

  • 00840682125260 ()


  • Radiological PACS software
MD CPACS RA1000 4.0 MEDICAL DEVICE
GE HEALTHCARE
CPACS RA1000 4.0
In Commercial Distribution

  • 00840682124447 ()


  • Radiological PACS software
No Description
GE HEALTHCARE
CPACS 4.0
In Commercial Distribution

  • 00840682124430 ()


  • Radiological PACS software
NIV plus Software Upgrade Option US;For 980 Series Ventilator
Covidien LP
980NIVPLUS-US
In Commercial Distribution

  • 10884521817609 ()


  • Ventilator application software
IE Sync Trigger Upgrade Option US;For 980 Series Ventilator
Covidien LP
980IESYNC-US
In Commercial Distribution

  • 10884521817593 ()


  • Ventilator application software
High Flow O2 Therapy Upgrade Option US;For 980 Series Ventilator
Covidien LP
980HFO2T-US
In Commercial Distribution

  • 10884521817586 ()


  • Ventilator application software
HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution

  • G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01

  • Cognitive assessment software
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
AMA Optics, Inc.
DiagnosticGame
In Commercial Distribution

  • G506DG010 ()
DG01

  • Vision self-testing software
No Description
SIRIS MEDICAL, INC.
IRT100
In Commercial Distribution

  • B244IRT1000 ()
IRT100

  • Radiation therapy software
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