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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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Phonetic Database Program, Software
PENTAX OF AMERICA, INC.
4332
Not in Commercial Distribution

  • 04961333229680 ()


  • Electroglottograph
Auditory Feedback Tools, Software
PENTAX OF AMERICA, INC.
3506
In Commercial Distribution

  • 04961333229628 ()
N/A

  • Electroglottograph
X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software
Software Package, AS 2.3
Omni Life Science, Inc.
NS-27111
In Commercial Distribution

  • 00841690194422 ()
NS-27111

  • Robotic surgical navigation system application software
MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software
syngo Application Software VD2
Siemens Healthcare GmbH
10849231
In Commercial Distribution

  • 04056869050874 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VD1
Siemens Healthcare GmbH
10849124
In Commercial Distribution

  • 04056869012902 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VE3
Siemens Healthcare GmbH
30000266
In Commercial Distribution

  • 04056869964546 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VE4
Siemens Healthcare GmbH
30000267
In Commercial Distribution

  • 04056869964539 ()


  • Basic diagnostic x-ray system application software
syngo Dynamics VA40 Software
Siemens Healthcare GmbH
10745960
In Commercial Distribution

  • 04056869253244 ()


  • Radiological PACS software
syngo Application Software VE2
Siemens Healthcare GmbH
11327667
In Commercial Distribution

  • 04056869124162 ()


  • Basic diagnostic x-ray system application software
FreeStyle Libre Pro Software
ABBOTT DIABETES CARE INC
75170
In Commercial Distribution

  • 30093815751701 ()
  • 00093815751700 ()
75170

  • Home healthcare information system application software
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
Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software
Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software
PULSE Software, Base Image
Nuvasive, Inc.
1802489
In Commercial Distribution

  • 00195377065506 ()


  • Orthopaedic stereotactic surgery system
Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


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

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software
DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered
Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system
TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting 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
OraCheck Software Version 5.0.0
SIRONA Dental Systems GmbH
6733336
In Commercial Distribution

  • E27667333360 ()


  • CAD/CAM software
Connect Software Version 5.1.0
SIRONA Dental Systems GmbH
6728815
In Commercial Distribution

  • E27667288150 ()


  • CAD/CAM software
CEREC Software Version 5.1.0
SIRONA Dental Systems GmbH
6716174
In Commercial Distribution

  • E27667161740 ()


  • CAD/CAM software
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