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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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ClearPoint - Software Version 2.0.3
Clearpoint Neuro, Inc.
CP-SFW-11-203
In Commercial Distribution

  • 00850359007003 ()
CP-SFW-11-203

  • Neurological stereotactic surgery system
ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software
SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer
ClearPoint Software Version 2.2
Clearpoint Neuro, Inc.
CP-SFW-11-22
In Commercial Distribution

  • 00850376007888 ()
CP-SFW-11-22

  • Neurological stereotactic surgery system
ClearPoint Software Version 2.1
Clearpoint Neuro, Inc.
CP-SFW-11-21
In Commercial Distribution

  • 00850376007703 ()
CP-SFW-11-21

  • Neurological stereotactic surgery system
Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software
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
INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
Vitek 2 software V10
BIOMERIEUX , INC.
10.0
In Commercial Distribution

  • 03573026618285 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VIDAS 3 V1.4 Software
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026617622 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
NeuroCatch Platform software NS20
NeuroCatch Inc
2.0
In Commercial Distribution

  • G134NS200 ()


  • Electroencephalograph
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 Eli Edit Standard
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023267 ()
107420

  • Electrocardiograph, professional, multichannel
Software Eli Edit Pro
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023250 ()
107422

  • Electrocardiograph, professional, multichannel
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
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
FreeStyle Libre Pro Software
ABBOTT DIABETES CARE INC
75170
In Commercial Distribution

  • 30093815751701 ()
  • 00093815751700 ()
75170

  • Home healthcare information system application software
X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.6.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022838 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.5.8 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022821 ()


  • Surgical planning/navigation-enhancement system
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