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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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VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521835870 ()


  • Multiparameter physiologic analysis workstation
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software
WinOMS Practice Management Software
CARESTREAM HEALTH, INC.
CS WinOMS
In Commercial Distribution

  • 60889978014576 ()
8014573

  • Physician-practice-management information system
M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder
M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder
CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971746849 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software
CS Orthodontic Imaging Software
CARESTREAM HEALTH, INC.
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60889971746832 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software
CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971546975 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software
VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

  • Computed radiography digital imaging scanner
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