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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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AGGRO/LINK WBA Software
CHRONO-LOG CORP
AGGRO/LINK WBA Software
In Commercial Distribution

  • 00811476011007 ()


  • Platelet aggregation analyser IVD
GEMS Mobile ECG software
CardioComm Solutions, Inc
GM
In Commercial Distribution

  • 00812324000297 ()
GM

  • Electrocardiograph, home-use
Aura:fit Software v 5.0
Unitron Hearing Division
058-5260
In Commercial Distribution

  • 07613389483895 ()
058-5260

  • Audiometric/hearing device software
TrueFit Software v 5.0
Unitron Hearing Division
058-5259
In Commercial Distribution

  • 07613389483888 ()
058-5259

  • Audiometric/hearing device software
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
SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software
FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software
Synergy Matrix Management Software
ARTHREX, INC.
AR-3200-1036
In Commercial Distribution

  • 00888867253902 ()
AR-3200-1036

  • Operating room audiovisual data/device management system
Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter
CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software
Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device
Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use
iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software
NeuroCatch Platform software NS20
NeuroCatch Inc
2.0
In Commercial Distribution

  • G134NS200 ()


  • Electroencephalograph
VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

  • Computed radiography digital imaging scanner
CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software
CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

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

  • 60889978014576 ()
8014573

  • Physician-practice-management information system
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
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