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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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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

Abbott - 00699073708519

Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70851
In Commercial Distribution

  • 30699073708510 ()
  • 00699073708519 ()
  • 00699073000842 ()
70851

  • Electrical-only medical device connection cable, reusable

Abbott - 00699073000842

Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70851
Not in Commercial Distribution

  • 30699073000843 ()
  • 00699073000842 ()
  • 99073-0708-51 ()
70851

  • Electrical-only medical device connection cable, reusable
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