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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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Somnolyzer Software Service 24x7
Respironics, Inc.
Somnolyzer Software Service 24x7 - 2
In Commercial Distribution

  • 00606959006164 ()
1084709

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

  • 09008737382087 ()


  • Audiometric/hearing device software
Software, Sleepware G3 (EN)
Respironics, Inc.
Sleepware G3 Software, English - 3
In Commercial Distribution

  • 00606959045255 ()
1082462

  • Polysomnography analyser
OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52275
Not in Commercial Distribution

  • 09008737522759 ()


  • 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
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
FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software
SOFTWARE 9733877 STEALTHVIZ LINUX
MEDTRONIC NAVIGATION, INC.
9733877
In Commercial Distribution

  • 00613994446060 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733878 STEALTHVIZ WIN32
MEDTRONIC NAVIGATION, INC.
9733878
In Commercial Distribution

  • 00613994446053 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733760 CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733760
In Commercial Distribution

  • 00613994445988 ()


  • Neurological stereotactic surgery system
X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software
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