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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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Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38208
In Commercial Distribution

  • 09008737382087 ()


  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36363
In Commercial Distribution

  • 09008737363635 ()


  • Audiometric/hearing device software
TRUST Dental CAD Software
Rgorithm Korea
V1.0
In Commercial Distribution

  • 08809965590005 ()


  • CAD/CAM software
Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software
Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000100683 ()


  • Radiology picture archiving and communication system workstation
Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
2.0
In Commercial Distribution

  • 00842000100669 ()


  • Radiology picture archiving and communication system workstation
SOFTWARE, AUTO NERV, MEB-9400
NIHON KOHDEN AMERICA, INC.
QP-948BK
In Commercial Distribution

  • 00841983101335 ()
QP-948BK

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

  • 00841983101328 ()
QP-947BK

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

  • 00841983101311 ()
QP-946BK

  • Evoked-potential graphic recording system
EEG examination support software
NIHON KOHDEN AMERICA, INC.
QP-150AK
In Commercial Distribution

  • 00841983101281 ()
QP-150AK

  • Electroencephalograph
Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
P803254
In Commercial Distribution

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set
SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software
SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system
Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system
Cytolink 1.0 Software DVD
Leica Biosystems Richmond, Inc.
23SW0001LNK
Not in Commercial Distribution

  • 00849832011569 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software
SOFTWARE KEY, USB HASP-4
PENTAX OF AMERICA, INC.
1111-1322
In Commercial Distribution

  • 04961333231157 ()


  • Electroglottograph
Educational Bundle, Speech Software
PENTAX OF AMERICA, INC.
5157
Not in Commercial Distribution

  • 04961333230051 ()


  • Electroglottograph
Signal Enhancement Program, Software
PENTAX OF AMERICA, INC.
5142
Not in Commercial Distribution

  • 04961333230044 ()


  • Electroglottograph
Motor Speech Products, Software
PENTAX OF AMERICA, INC.
5141
In Commercial Distribution

  • 04961333229802 ()


  • Electroglottograph
Real-Time EGG Analysis Software
PENTAX OF AMERICA, INC.
5138
In Commercial Distribution

  • 04961333229796 ()


  • Electroglottograph
Analysis-Synthesis Laboratory (ASL) Software
PENTAX OF AMERICA, INC.
5104
Not in Commercial Distribution

  • 04961333229734 ()


  • Electroglottograph
Palatometer Database Program, Software
PENTAX OF AMERICA, INC.
4333
Not in Commercial Distribution

  • 04961333229697 ()


  • Electroglottograph
Phonetic Database Program, Software
PENTAX OF AMERICA, INC.
4332
Not in Commercial Distribution

  • 04961333229680 ()


  • Electroglottograph
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333236565 ()


  • Electroglottograph
CAPE V SOFTWARE MODULE
PENTAX OF AMERICA, INC.
5168
In Commercial Distribution

  • 04961333235421 ()


  • Electroglottograph
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
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