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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AlignRT 6.0 software
VISION RT LIMITED
AlignRT 6.0
Not in Commercial Distribution

  • 05056190500177 ()


  • Radiological video camera patient positioning/tracking system
AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system
3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software
Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system
Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
7.0
In Commercial Distribution

  • 00850000065000 ()
N/A

  • Radiation therapy software
Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software
Quality Control Software
EIZO CORPORATION
Ver.5.2.x
In Commercial Distribution

  • 04995047067740 ()
RadiCS

  • Radiology workstation display quality assurance software
Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution

  • 04987670100451 ()


  • Diagnostic x-ray digital imaging system workstation application software
NASOMETER II (SOFTWARE)
PENTAX OF AMERICA, INC.
6450
In Commercial Distribution

  • 04961333236558 ()


  • Electroglottograph
Real-Time Spectrogram Software
PENTAX OF AMERICA, INC.
5129
In Commercial Distribution

  • 04961333229789 ()


  • Electroglottograph
Real-Time Pitch Software
PENTAX OF AMERICA, INC.
5121
In Commercial Distribution

  • 04961333229765 ()


  • Electroglottograph
Upgrade - Software Only
PENTAX OF AMERICA, INC.
5298 VU
Not in Commercial Distribution

  • 04961333230389 ()


  • Electroglottograph
Exercise test software
NIHON KOHDEN CORPORATION
QP-156E
Not in Commercial Distribution

  • 04931921113400 ()
QP-156E

  • Electrocardiograph, professional, multichannel
Digital video software
NIHON KOHDEN CORPORATION
QP-110AK
In Commercial Distribution

  • 04931921100769 ()
QP-110AK

  • Electroencephalograph
UPGRADE SOFTWARE PROGRAM
NIHON KOHDEN CORPORATION
QS-010BK
In Commercial Distribution

  • 04931921006429 ()


  • Evoked-potential graphic recording system
Software Upgrade Kit
RESMED PTY LTD
19948
In Commercial Distribution

  • 00619498199488 ()
19948

  • Portable electric ventilator
SureSmile Advanced Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007108 ()
DIGI-500159

  • CAD/CAM software
SOFTWARE COMPASS GPS
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256819 ()
21041979

  • Audiometric/hearing device software
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800022
In Commercial Distribution

  • 05415067047212 ()
H800022

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800007
In Commercial Distribution

  • 05415067035585 ()
H800007

  • Cardiac catheterization monitoring system
System Software Upgrade
ST. JUDE MEDICAL, INC.
H702602
In Commercial Distribution

  • 05415067033178 ()
H702602

  • Cardiac mapping system application software
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1014666
In Commercial Distribution

  • 05415067030856 ()
1014666

  • Coronary optical coherence tomography system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
1014661
In Commercial Distribution

  • 05415067030108 ()
1014661

  • Cardiac catheterization laboratory computer
  • Coronary optical coherence tomography system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067030009 ()
H1014680

  • Cardiac catheterization laboratory computer
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067029997 ()
H1014670

  • Cardiac catheterization laboratory computer
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023711 ()
MG1000

  • Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Module
In Commercial Distribution

  • 05415067023223 ()
H702322

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Module
In Commercial Distribution

  • 05415067023216 ()
H702321

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067023209 ()

  • Height: 8.5 Inch
  • Depth: 16.8 Inch
  • Width: 16.8 Inch
  • Weight: 33.4 Pound
H702320

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067020185 ()
H702018

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067018519 ()
MG1000

  • Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H701485
In Commercial Distribution

  • 05415067014856 ()
H701485

  • Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H700386
In Commercial Distribution

  • 05415067003867 ()
H700386

  • Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution

  • 05415067003560 ()
100043247

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
100041650
In Commercial Distribution

  • 05415067003553 ()
100041650

  • Cardiac catheterization monitoring system
NX 2.0 SOFTWARE
AGFA
2.0.
In Commercial Distribution

  • 05414904217818 ()
E1AMX

  • Radiology DICOM image processing application software
Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer
Patient Transmitter Software
ST. JUDE MEDICAL, INC.
LSRM1000
In Commercial Distribution

  • 05415067049971 ()
LSRM1000

  • Transtelephonic implantable pacemaker analysis system
SureSmile Ortho Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007092 ()
DIGI-500153

  • CAD/CAM software
Office Medic Software
VECTRACOR INC
6.0
In Commercial Distribution

  • 00857175006166 ()


  • Cardiopulmonary physiological parameter analysis software
Dental CAD Software
3shape A/S
2017-1 (R1.1)
In Commercial Distribution

  • 05902729752237 ()


  • CAD/CAM software
Dental CAD Software
3shape A/S
R1.1
In Commercial Distribution

  • 05902729752220 ()


  • CAD/CAM software
SOFTWARE CONNEXX 9.11
Ws Audiology Usa, Inc.
Connexx 9.11
In Commercial Distribution

  • 05714880200003 ()
21026507

  • Audiometric/hearing device software
SOFTWARE CONNEXX 9.9
Ws Audiology Usa, Inc.
Connexx 9.9
In Commercial Distribution

  • 05714880182354 ()
21022254

  • Audiometric/hearing device software
SOFTWARE CONNEXX 9.8
Ws Audiology Usa, Inc.
Connexx 9.8
In Commercial Distribution

  • 05714880169393 ()
21016993

  • Audiometric/hearing device software
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