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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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Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

EncoreAnywhere - 00606959047228

EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
1119756

  • Medical equipment clinical data interfacing software

EncoreAnywhere - 00606959042902

EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software

EPIQ Elite Diamond Select Ultrasound - 00884838109971

To support the 7.x software version
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838109971 ()


  • General-purpose ultrasound imaging system

Guideline™ 4000 - 00873263008645

Guideline™ 4000 5.0 Software, Version 2.2.0
FHC, INC.
C0217-00864
In Commercial Distribution

  • 00873263008645 ()
C0217

  • Neurophysiologic monitoring system
  • Electroencephalograph

ROMA - 00869164000024

ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Fujirebio Diagnostics, Inc.
404-10US
In Commercial Distribution

  • 00869164000024 ()


  • Laboratory instrument/analyser application software IVD

WayPoint™ Navigator - 00873263004333

microTargeting WayPoint Navigato, Laptop and Software, 1x
FHC, INC.
66-WP-NV(4.2)-00433
Not in Commercial Distribution

  • 00873263004333 ()
66-WP-NV(4.2)

  • Neurological stereotactic surgery system

XrayVision DCV - 00685031000023

Dental imaging capture, enhance and display software.
APTERYX INC
3
In Commercial Distribution

  • 00685031000023 ()


  • General-purpose dental x-ray system application software

XVlite - 00685031000016

Dental imaging capture, enhance and display software.
APTERYX INC
3
Not in Commercial Distribution

  • 00685031000016 ()


  • General-purpose dental x-ray system application software

XrayVision - 00685031000009

Dental imaging capture, enhance and display software.
APTERYX INC
4
Not in Commercial Distribution

  • 00685031000009 ()


  • General-purpose dental x-ray system application software
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