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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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Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only
Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software
VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device
Sona-Match, Software
PENTAX OF AMERICA, INC.
5127
In Commercial Distribution

  • 04961333229772 ()


  • Electroglottograph
Multi-Speech Software
PENTAX OF AMERICA, INC.
3700
In Commercial Distribution

  • 04961333229642 ()


  • Electroglottograph
LiPAScan software
Siemens Healthcare Diagnostics Inc.
10492006
In Commercial Distribution

  • 00630414000534 ()
10492006

  • Laboratory instrument/analyser application software IVD
Games, Software
PENTAX OF AMERICA, INC.
5167B
In Commercial Distribution

  • 04961333229987 ()


  • Electroglottograph
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
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