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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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Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software
Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph
Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph
Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
SOFTWARE 9733808 DICOM Q/R
MEDTRONIC NAVIGATION, INC.
9733808
In Commercial Distribution

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00613994422385 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00613994408174 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
SOFTWARE 9733260 AXIEM CRANIAL INAV
MEDTRONIC NAVIGATION, INC.
9733260
In Commercial Distribution

  • 00613994231383 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9734150 UNIVERSAL ITHR S7
MEDTRONIC NAVIGATION, INC.
9734150
In Commercial Distribution

  • 00613994570369 ()


  • Orthopaedic stereotactic surgery system
SOFTWARE 9734149 UNIVERSAL ITKR S7
MEDTRONIC NAVIGATION, INC.
9734149
In Commercial Distribution

  • 00613994570352 ()


  • Orthopaedic stereotactic surgery system
SOFTWARE 9734108 StealthViz INT WIN32
MEDTRONIC NAVIGATION, INC.
9734108
In Commercial Distribution

  • 00613994556127 ()


  • Neurological stereotactic surgery system
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
SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system
SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-45
In Commercial Distribution

  • 04048551357286 ()


  • Operating room audiovisual data/device management system application software
SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001S432
In Commercial Distribution

  • 04048551325117 ()


  • Operating room audiovisual data/device management system
SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-44
In Commercial Distribution

  • 04048551329856 ()


  • Operating room audiovisual data/device management system application software
KARL STORZ SCB Software Upgrade
Karl Storz GmbH & Co. KG
20090001-28
In Commercial Distribution

  • 04048551060599 ()


  • Operating room audiovisual data/device management system application software
BD FACSCanto™ System Software
Becton, Dickinson And Company
664126
In Commercial Distribution

  • 00382906641267 ()
664126

  • Laboratory analyser operation system software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664122
In Commercial Distribution

  • 00382906641229 ()
664122

  • Laboratory analyser operation system software IVD
BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664118
In Commercial Distribution

  • 00382906641182 ()
664118

  • Laboratory analyser operation system software IVD
BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664117
In Commercial Distribution

  • 00382906641175 ()
664117

  • Laboratory instrument/analyser application software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664114
In Commercial Distribution

  • 00382906641144 ()
664114

  • Laboratory analyser operation system software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664112
In Commercial Distribution

  • 00382906641120 ()
664112

  • Laboratory analyser operation system software IVD
BD FACSCanto System Software V2.4
BECTON, DICKINSON AND COMPANY
646600
Not in Commercial Distribution

  • 00382906466006 ()
646600

  • Laboratory instrument/analyser application software IVD
BD® HLA-B27 Software v5.1
BECTON, DICKINSON AND COMPANY
643438
Not in Commercial Distribution

  • 00382906434388 ()
643438

  • Laboratory instrument/analyser application software IVD
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


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

  • 00382830059541 ()


  • Electroencephalograph
Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph
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