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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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CEREC Guide Drill Key M Ø3.6
SIRONA Dental Systems GmbH
6237494
In Commercial Distribution

  • E27662374942 ()


  • CAD/CAM software
SIDEXIS XG Basis-DVD
SIRONA Dental Systems GmbH
6229129
Not in Commercial Distribution

  • E27662291290 ()


  • Radiological PACS software
NIV plus Software Upgrade Option US;For 980 Series Ventilator
Covidien LP
980NIVPLUS-US
In Commercial Distribution

  • 10884521817609 ()


  • Ventilator application software
IE Sync Trigger Upgrade Option US;For 980 Series Ventilator
Covidien LP
980IESYNC-US
In Commercial Distribution

  • 10884521817593 ()


  • Ventilator application software
High Flow O2 Therapy Upgrade Option US;For 980 Series Ventilator
Covidien LP
980HFO2T-US
In Commercial Distribution

  • 10884521817586 ()


  • Ventilator application software
Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
4
In Commercial Distribution

  • 08436567540017 ()


  • Radiation therapy software
Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
3
In Commercial Distribution

  • 08436567540000 ()


  • Radiation therapy software
No Description
ESSILOR INTERNATIONAL
ANAEYES OCT
In Commercial Distribution

  • 03615020000496 ()


  • Camera application software
AVEA NIMV+VG SW KEY
Carefusion Corporation
63865
Not in Commercial Distribution

  • 10846446017564 ()


  • Ventilator application software
ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software
ResScan v7.0.1
RESMED CORP.
31338
In Commercial Distribution

  • 08401934313389 ()


  • Ventilator application software
No Description
Prowess, Inc.
version 5.0
Not in Commercial Distribution

  • 01868603000212 ()


  • Radiation therapy software
Zimmer PSIP
Materialise NV
Zimmer PSIP
Not in Commercial Distribution

  • E314ZIMMERPSIP0 ()
Zimmer PSIP

  • CAD/CAM software
Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution

  • E314ZIMMERPSIOMS0 ()
Zimmer online management system

  • CAD/CAM software
SurgiCase Viewer
Materialise NV
SurgiCase Viewer
In Commercial Distribution

  • E314SURGICASEVIEWER0 ()
SurgiCase Viewer

  • CAD/CAM software
SurgiCase Transfer
Materialise NV
SurgiCase Transfer
In Commercial Distribution

  • E314SURGICASETRANSFER0 ()
SurgiCase Transfer

  • CAD/CAM software
SurgiCase Shoulder Planner
Materialise NV
SurgiCase Shoulder Planner
In Commercial Distribution

  • E314SURGICASESHOULPLAN0 ()
SurgiCase Shoulder Planner

  • CAD/CAM software
SurgiCase Planner
Materialise NV
SurgiCase Planner
Not in Commercial Distribution

  • E314SURGICASEPLANNER0 ()
SurgiCase Planner

  • CAD/CAM software
SurgiCase OOS
Materialise NV
SurgiCase OOS
In Commercial Distribution

  • E314SURGICASEOOS0 ()
SurgiCase OOS

  • CAD/CAM software
SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
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