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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Progeny Imaging Software
MIDMARK CORPORATION
500-427
In Commercial Distribution

  • 00841709105661 ()
500-427

  • General-purpose dental x-ray system application software
Application System Software
Omni Life Science, Inc.
2205-2000
In Commercial Distribution

  • 00841690194699 ()
2205-2000

  • Robotic surgical navigation system application software
Knee Software Package
Omni Life Science, Inc.
NS-27003
In Commercial Distribution

  • 00841690194545 ()
NS-27003

  • Instrument tray, reusable
EncorePro2 Software (Web)
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959053786 ()
1099731

  • Medical equipment clinical data interfacing software
EncorePro 2, Software
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050778 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050761 ()
1099731

  • Medical equipment clinical data interfacing software
EncorePro 2, Software
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048348 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048331 ()
1099731

  • Medical equipment clinical data interfacing software
FLUOROSCOPY SOFTWARE 2.3
Stryker Leibinger GmbH & Co. KG
6004-650-000
In Commercial Distribution

  • 04546540505712 ()
6004-650-000

  • Robotic surgical navigation system application software
Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder
OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system
EncorePro 2, Software
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959043114 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959042957 ()
1099731

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.19
In Commercial Distribution

  • 00606959040434 ()
1099731

  • Medical equipment clinical data interfacing software
myQA Daily Software
IBA Dosimetry GmbH
DQ00000
In Commercial Distribution

  • EIBADQ000000 ()
DQ00-000

  • Accelerator system quality assurance device
myQA iON software
IBA Dosimetry GmbH
MQ10-000
In Commercial Distribution

  • EIBAMQ100000 ()


  • Accelerator system quality assurance device
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software
UDI Software Pristina
GE MEDICAL SYSTEMS
PRISTINA 2.8.3
In Commercial Distribution

  • 00195278711229 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6
In Commercial Distribution

  • 00842000101178 ()


  • Radiology picture archiving and communication system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000101116 ()


  • Radiology picture archiving and communication system workstation
Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.4
In Commercial Distribution

  • 00842000101031 ()


  • Radiology picture archiving and communication system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
12.1
In Commercial Distribution

  • 00842000100928 ()


  • Radiological PACS software
Software implant template
MERGE HEALTHCARE SOLUTIONS INC.
40.2.2
In Commercial Distribution

  • 00842000100904 ()


  • Surgical implant template, reusable
Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100881 ()


  • Radiology picture archiving and communication system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.3
Not in Commercial Distribution

  • 00842000100867 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.3
Not in Commercial Distribution

  • 00842000100850 ()


  • Radiological PACS software
Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.2
In Commercial Distribution

  • 00842000100638 ()


  • Radiology picture archiving and communication system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.1.0
In Commercial Distribution

  • 00842000100607 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100591 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.4
Not in Commercial Distribution

  • 00842000100584 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100577 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100560 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.1 Patch 1
Not in Commercial Distribution

  • 00842000100553 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100508 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100416 ()


  • Radiology picture archiving and communication system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100348 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.2
In Commercial Distribution

  • 00842000100331 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.3
Not in Commercial Distribution

  • 00842000100317 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100294 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100287 ()


  • Radiological PACS software
Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100126 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.2
Not in Commercial Distribution

  • 00842000100096 ()


  • Radiological PACS software
Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
7.1.1
In Commercial Distribution

  • 00842000100089 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.1.1
In Commercial Distribution

  • 00842000100072 ()


  • Radiological PACS software
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.1.2
In Commercial Distribution

  • 00842000100058 ()


  • Radiological PACS software
Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100041 ()


  • Radiological PACS software
Exercise test software
NIHON KOHDEN AMERICA, INC.
QP-156E
Not in Commercial Distribution

  • 00841983101298 ()
QP-156E

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

  • 00841983101274 ()
QP-110AK

  • Electroencephalograph
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