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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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1.0 Software Update vF.0.1
ST. JUDE MEDICAL, INC.
1015191
In Commercial Distribution

  • 05415067045331 ()
1015191

  • Coronary optical coherence tomography system
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
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
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 Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
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