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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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SoundWave™ Professional Suite Software - 07630016854262

3.1
Advanced Bionics AG
CI-6055-011
Not in Commercial Distribution

  • 07630016854927 ()
  • 07630016854262 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 07630016853227

No Description
Advanced Bionics AG
CI-6055-014
Not in Commercial Distribution

  • 07630016853227 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 07630016850578

3.1
Advanced Bionics AG
CI-6055-011
Not in Commercial Distribution

  • 07630016850585 ()
  • 07630016850578 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 07630016842177

2.3
Advanced Bionics AG
CI-6055-009
Not in Commercial Distribution

  • 07630016833915 ()
  • 07630016842177 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software 3.0 - 07630016826382

No Description
Advanced Bionics AG
CI-6055-010
Not in Commercial Distribution

  • 07630016842566 ()
  • 07630016826382 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 07630016816925

2.2.25
Advanced Bionics, LLC
CI-6055-008
Not in Commercial Distribution

  • 07630016816925 ()


  • Audiometric/hearing device software

SCLIN 2000Device Fitting - 07630016804335

No Description
Advanced Bionics, LLC
AB-6052CD
Not in Commercial Distribution

  • 07630016804335 ()


  • Audiometric/hearing device software

Powerheart® MDLink - 00812394020393

MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution

  • 00812394020393 ()
400621-045

  • External defibrillator application software

AED Manager, Powerheart G5 - 00812394020188

Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution

  • 00812394020188 ()
XAEDMGR01D

  • External defibrillator application software

D2P - 00816847021470

The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. This modular package includes, but is not limited to the following functions: - DICOM viewer and analysis - Automated segmentation - Editing and pre-printing - Seamless integration with 3D Systems printers - Seamless integration with 3D Systems software packages
3D SYSTEMS, INC.
1.0.2
In Commercial Distribution

  • 00816847021470 ()


  • Image segmentation application software
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