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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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TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software
USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software
DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software
IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner
ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software
TIP, PROFUSION, MACH XL WITH SOFTWARE
SOLTA MEDICAL
40-01746
In Commercial Distribution

  • 00816995020615 ()
40-01746

  • Multi-modality skin surface treatment system
Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system
Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system
Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system
Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-005-70
In Commercial Distribution

  • 00817655021430 ()


  • Electrocardiography telemetric monitoring system
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