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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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Orthex - 00841731119209

Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software

Midmark Progeny Imaging Software - 00841709101410

X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101403

X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101397

X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101380

X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101373

X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software

OMNIBotics - 00841690194422

Software Package, AS 2.3
Omni Life Science, Inc.
NS-27111
In Commercial Distribution

  • 00841690194422 ()
NS-27111

  • Robotic surgical navigation system application software

SpecialsLab - 00840682123587

SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Mac-Lab - 00840682123556

SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

AEOS - 04046955206803

SOFTWARE MODULE DIR 800
Aesculap AG
PV023
In Commercial Distribution

  • 04046955206803 ()
PV023

  • Surgical microscope fluorescent angiography system

AESCULAP - 04046955206797

SOFTWARE MODULE DUV 400
Aesculap AG
PV022
In Commercial Distribution

  • 04046955206797 ()
PV022

  • Neurosurgical microscope

AESCULAP - 04046963181901

ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

NA - 00643169719972

SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software

N/A - 04961333230051

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

  • 04961333230051 ()


  • Electroglottograph

N/A - 04961333230044

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

  • 04961333230044 ()


  • Electroglottograph

REAL-TIME - 04961333229796

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

  • 04961333229796 ()


  • Electroglottograph

N/A - 04961333229680

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

  • 04961333229680 ()


  • Electroglottograph
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