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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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Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


  • Electronic acoustic stethoscope
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver
MicroTargeting Guidline 4000 5.0 Software 1x
FHC, INC.
C0217-00679
In Commercial Distribution

  • 00873263006795 ()
C0217

  • Neurophysiologic monitoring system
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
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