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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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tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution

  • 15099590572679 ()
6915050

  • Laboratory instrument/analyser application software IVD
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD
moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.
MOOR INSTRUMENTS LIMITED
4
In Commercial Distribution

  • 15060484490096 ()


  • Tissue saturation oximeter
  • Laser Doppler blood flowmeter
ApolloKnee Software
CORIN LTD
TKR.SS.0001
In Commercial Distribution

  • 05056139245862 ()


  • Robotic surgical arm system
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software
TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
NASOMETER SOFTWARE
PENTAX OF AMERICA, INC.
6500
In Commercial Distribution

  • 04961333247301 ()


  • Speech assistive training device
VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device
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