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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, AUTO NERV, MEB-9400
NIHON KOHDEN CORPORATION
QP-948BK
In Commercial Distribution

  • 04931921104842 ()
QP-948BK

  • Evoked-potential graphic recording system
SOFTWARE, SINGLE FIBER, MEB-9400
NIHON KOHDEN CORPORATION
QP-947BK
In Commercial Distribution

  • 04931921104835 ()
QP-947BK

  • Evoked-potential graphic recording system
SOFTWARE, QUANT EMG , MEB-9400
NIHON KOHDEN CORPORATION
QP-946BK
In Commercial Distribution

  • 04931921104828 ()
QP-946BK

  • Evoked-potential graphic recording system
EEG examination support software
NIHON KOHDEN CORPORATION
QP-150AK
In Commercial Distribution

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph
SOFTWARE 9734620 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734620
In Commercial Distribution

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable
SOFTWARE 9734220 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734220
In Commercial Distribution

  • 00613994596826 ()


  • Neurological stereotactic surgery system
Genie Medical fitting software
Oticon Medical AB
M50504
In Commercial Distribution

  • 05712149000777 ()
M50504

  • Audiometric/hearing device software
Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system
Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device
DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software
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