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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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SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


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

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system
Software Upgrade, LiDCOunity v1.01 (b1943)
LIDCO LIMITED
Li11238
In Commercial Distribution

  • 05060110523016 ()
Li11238

  • General-purpose multi-parameter bedside monitor
Software Upgrade, LiDCOunity v2.03 (b318)
LIDCO LIMITED
Li11197
In Commercial Distribution

  • 05060110522934 ()
Li11197

  • General-purpose multi-parameter bedside monitor
Software Upgrade, LiDCOrapid v2.06 (b1328)
LIDCO LIMITED
Li11151
In Commercial Distribution

  • 05060110522613 ()
Li11151

  • General-purpose multi-parameter bedside monitor
Software Upgrade, LiDCOunity v1.01 (b1935)
LIDCO LIMITED
Li11150
In Commercial Distribution

  • 05060110522156 ()
Li11150

  • General-purpose multi-parameter bedside monitor
Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
SOFTWARE KIT 9735235 MICROSCOPE ROBOTICS
MEDTRONIC NAVIGATION, INC.
9735235
In Commercial Distribution

  • 00643169272583 ()


  • Neurological stereotactic surgery system
HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
PENTAX OF AMERICA, INC.
HITACHI5.1UPGRD
In Commercial Distribution

  • 04961333243105 ()


  • General-purpose ultrasound imaging system
Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph
Phonetic & Perception Simulation Program, Software
PENTAX OF AMERICA, INC.
5151
Not in Commercial Distribution

  • 04961333229826 ()


  • Electroglottograph
Multi-Dimensional Voice Program (MDVP) Software
PENTAX OF AMERICA, INC.
5105
In Commercial Distribution

  • 04961333229741 ()


  • Electroglottograph
SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN CORPORATION
QP-260BK
In Commercial Distribution

  • 04931921113080 ()
QP-260BK

  • Evoked-potential graphic recording system
Software Kit (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
QS-127P
In Commercial Distribution

  • 04931921006689 ()
QS-127P

  • General-purpose multi-parameter bedside monitor
Software Kit (for CU-151R, CU-152R)
NIHON KOHDEN CORPORATION
QS-116P
In Commercial Distribution

  • 04931921002179 ()
QS-116P

  • General-purpose multi-parameter bedside monitor
SOFTWARE 9734587 3D FLUORO CALIBRATION
MEDTRONIC NAVIGATION, INC.
9734587
In Commercial Distribution

  • 00613994753106 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9734400XOM STEALTHMERGE ENT PG
MEDTRONIC NAVIGATION, INC.
9734400XOM
In Commercial Distribution

  • 00613994680891 ()


  • Multi-purpose stereotactic surgery system
Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
2.1
In Commercial Distribution

  • 00856826006210 ()
610525

  • Human genomic analysis interpretive software
Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
1.2
In Commercial Distribution

  • 00856826006074 ()
610525

  • Human genomic analysis interpretive software
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