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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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sterEOS® - 03663999000047

sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution

  • 03663999000047 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000023

sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software

Will3D - 08800005200298

Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution

  • 08800005200298 ()


  • General-purpose dental x-ray system application software

WillCeph - 08800005200168

WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
HDX WILL CORP.
WillCeph
In Commercial Distribution

  • 08800005200168 ()


  • General-purpose dental x-ray system application software

NA - 10886704064947

Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution

  • 10886704064947 ()
  • 10886704071426 ()
914205US

  • Infusion pump programmer

MAR - 00840682134989

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software

ASiR-V - 00840682134972

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software

Proteus Digital Health Feedback System - 10856602005144

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2008
In Commercial Distribution

  • 10856602005144 ()


  • Medication adherence telemetric monitoring system, post-ingestion

Emprint - 10884521214026

Ablation Planning Application
Covidien LP
CAMPA
Not in Commercial Distribution

  • 10884521214026 ()


  • CT system application software

Emprint - 10884521214019

VATS Planning Application
Covidien LP
CAMPV
Not in Commercial Distribution

  • 10884521214019 ()


  • CT system application software
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