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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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Natus - 00382830062213

Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph

Natus - 00382830062206

Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph

Xltek - 00382830061742

NeuroWorks/SleepWorks 10.0.1 Software (US)
XLTEK
041904
In Commercial Distribution

  • 00382830061742 ()


  • Electroencephalograph

Xltek - 00382830059541

NeuroWorks/SleepWorks 9.3.1 Software (US)
XLTEK
034879
In Commercial Distribution

  • 00382830059541 ()


  • Electroencephalograph

Keypoint - 00382830050999

VIR SOFTWARE, EDX - EMG/ NCS
NATUS MANUFACTURING LIMITED
9033S0511
In Commercial Distribution

  • 00382830050999 ()
9033S0511

  • Electromyograph

Xltek - 00382830048293

NeuroWorks/SleepWorks 9.2.1 Software (US)
XLTEK
024503
In Commercial Distribution

  • 00382830048293 ()


  • Electroencephalograph

Xltek - 00382830048279

NeuroWorks/SleepWorks 9.2.0 Software (INTL)
XLTEK
024501
In Commercial Distribution

  • 00382830048279 ()


  • Electroencephalograph

Xltek - 00382830048255

NeuroWorks/SleepWorks 9.1.1 Software (US)
XLTEK
024497
In Commercial Distribution

  • 00382830048255 ()


  • Electroencephalograph

Xltek - 00382830048231

NeuroWorks/SleepWorks 9.1.0 Software (INTL)
XLTEK
024495
In Commercial Distribution

  • 00382830048231 ()


  • Electroencephalograph

Leica Biosystems Ariol Review Software - 00849832003830

Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

PREIRUS - 04961333243105

HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
PENTAX OF AMERICA, INC.
HITACHI5.1UPGRD
In Commercial Distribution

  • 04961333243105 ()


  • General-purpose ultrasound imaging system

N/A - 04961333229864

Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph

N/A - 04961333229826

Phonetic & Perception Simulation Program, Software
PENTAX OF AMERICA, INC.
5151
Not in Commercial Distribution

  • 04961333229826 ()


  • Electroglottograph

MDVP - 04961333229741

Multi-Dimensional Voice Program (MDVP) Software
PENTAX OF AMERICA, INC.
5105
In Commercial Distribution

  • 04961333229741 ()


  • Electroglottograph

Kosmos OTS - 09353278000588

Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software

Cochlear - 09321502046503

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software

Cochlear - 09321502044905

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software

Cochlear - 09321502044899

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software

Compumedics Grael - 09342451001313

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

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph

Compumedics Grael - 09342451001290

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

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph
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