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

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
Protocol Plus Software version 10.3
G&J Electronics Inc
PPS-10.3
In Commercial Distribution

  • 00627843670957 ()


  • Gastrointestinal barostat
Protocol Plus Version 9.8 software
G&J Electronics Inc
PPS-9.8
In Commercial Distribution

  • 00627843670940 ()


  • Gastrointestinal barostat
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
Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder
Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser
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