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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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GammaPod™ Treatment Control System - 00850002615012

TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software

NASOMETER - 04961333247301

NASOMETER SOFTWARE
PENTAX OF AMERICA, INC.
6500
In Commercial Distribution

  • 04961333247301 ()


  • Speech assistive training device

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750382

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

ViewMate™ - 05415067030733

Software Upgrade
ST. JUDE MEDICAL, INC.
H900004
In Commercial Distribution

  • 05415067030733 ()
H900004

  • General-purpose ultrasound imaging system

EnSite Precision™ - 05415067030085

Software Installation
ST. JUDE MEDICAL, INC.
H702469-SW
In Commercial Distribution

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software
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