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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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Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph
NeuroWorks/SleepWorks 10.0.1 Software (US)
XLTEK
041904
In Commercial Distribution

  • 00382830061742 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.3.1 Software (US)
XLTEK
034879
In Commercial Distribution

  • 00382830059541 ()


  • Electroencephalograph
Synergy EDX Application Software CD
NATUS NEUROLOGY INCORPORATED
482-645900
In Commercial Distribution

  • 00382830038027 ()


  • Electromyograph
EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph
EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph
EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph
Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph
Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph
Software Pristina 8.4 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.6
In Commercial Distribution

  • 00195278866899 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
UDI Software Pristina ME 9.1
GE MEDICAL SYSTEMS
PRISTINA ME 9.1
In Commercial Distribution

  • 00195278716026 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
Software Pristina 8.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.2
In Commercial Distribution

  • 00195278655141 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software
Software Pristina 8.3 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.4
In Commercial Distribution

  • 00195278795724 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
Software Pristina 8.1 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8
In Commercial Distribution

  • 00195278560049 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
HL-7 INTERFACE FOR NEUROWORKBENCH SOFTWARE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7CS
In Commercial Distribution

  • 00841983103636 ()
A/NWB-HL7CS

  • Medical networking interface unit
SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN AMERICA, INC.
QP-260BK
In Commercial Distribution

  • 00841983102219 ()
QP-260BK

  • Evoked-potential graphic recording system
ORTHOPILOT SOFTWARE THA CUP ONLY
Aesculap AG
FS219
Not in Commercial Distribution

  • 04046963372446 ()
FS219

  • Robotic surgical navigation system application software
PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software
Site~Rite 9 Ultrasound Software
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution

  • 00801741231124 ()
SR9v1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system
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