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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
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