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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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Software Eli Edit Pro
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023250 ()
107422

  • Electrocardiograph, professional, multichannel
SOFTWARE E-SCRIBE WORKSTATION V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020686 ()
11012-016-51

  • Patient health record information system application software
SOFTWARE E-SCRIBE SERVER V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020679 ()
11012-016-50

  • Patient health record information system application software
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11100-005-50
In Commercial Distribution

  • 00817655022642 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
NeuroCatch Platform software NS20
NeuroCatch Inc
2.0
In Commercial Distribution

  • G134NS200 ()


  • Electroencephalograph
X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system
Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software
Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system
Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software
TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software
Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121940202000 ()


  • CT system application software
Monarch Software Cart v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121930202000 ()


  • Robotic surgical system application software
Monarch Software Tower v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121920202000 ()


  • Robotic surgical system application software
Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121900201060 ()


  • CT system application software
Monarch Software Cart v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121890201060 ()


  • Robotic surgical system application software
Monarch Software Tower v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121880201060 ()


  • Robotic surgical system application software
SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software
DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered
SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software
INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
Review Software (Single User)
NATUS MANUFACTURING LIMITED
9033S0628
In Commercial Distribution

  • 00382830050302 ()
9033S0628

  • Electromyograph
FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software
NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph
RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software
RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software
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