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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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X-Guide 3.1.1 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021893 ()


  • Surgical planning/navigation-enhancement system
TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software
DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered
Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software
SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software
Software Version 6.X
Philips Ultrasound LLC
795186
In Commercial Distribution

  • 00884838114470 ()


  • General-purpose ultrasound imaging system
Software Version 6.X
Philips Ultrasound LLC
795185
In Commercial Distribution

  • 00884838114463 ()


  • General-purpose ultrasound imaging system
Software Version 6.X
Philips Ultrasound LLC
795187
In Commercial Distribution

  • 00884838114456 ()


  • General-purpose ultrasound imaging system
NeoPac Software with Manual
ASTORIA-PACIFIC, INC.
307-C001-00
In Commercial Distribution

  • 00725609000434 ()
307-C001-00

  • Laboratory instrument/analyser application software IVD
UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software
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