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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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NA - 04931921104842

SOFTWARE, AUTO NERV, MEB-9400
NIHON KOHDEN CORPORATION
QP-948BK
In Commercial Distribution

  • 04931921104842 ()
QP-948BK

  • Evoked-potential graphic recording system

NA - 04931921104835

SOFTWARE, SINGLE FIBER, MEB-9400
NIHON KOHDEN CORPORATION
QP-947BK
In Commercial Distribution

  • 04931921104835 ()
QP-947BK

  • Evoked-potential graphic recording system

NA - 04931921104828

SOFTWARE, QUANT EMG , MEB-9400
NIHON KOHDEN CORPORATION
QP-946BK
In Commercial Distribution

  • 04931921104828 ()
QP-946BK

  • Evoked-potential graphic recording system

NA - 04931921100783

EEG examination support software
NIHON KOHDEN CORPORATION
QP-150AK
In Commercial Distribution

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph

N/A - 00613994776730

SOFTWARE 9734620 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734620
In Commercial Distribution

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable

DOSE IQ SAFETY SOFTWARE - 10085412676613

Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.8
In Commercial Distribution

  • 10085412676613 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software

N/A - 00613994596826

SOFTWARE 9734220 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734220
In Commercial Distribution

  • 00613994596826 ()


  • Neurological stereotactic surgery system

Flyte - 04546540591630

Charger Software Upgrade Kit
STRYKER CORPORATION
0408655200
In Commercial Distribution

  • 04546540591630 ()
0408655200

  • Surgical helmet system

ORTHOMAP - 04546540651600

ORTHOMAP¿ 3D 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6005-660-000
In Commercial Distribution

  • 04546540651600 ()
6005-660-000

  • Robotic surgical navigation system application software

N/Al - 04961333231157

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

  • 04961333231157 ()


  • Electroglottograph

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

N/A - 04961333229802

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

  • 04961333229802 ()


  • Electroglottograph

REAL-TIME - 04961333229796

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

  • 04961333229796 ()


  • Electroglottograph

ASL - 04961333229734

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

  • 04961333229734 ()


  • Electroglottograph

N/A - 04961333229697

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

  • 04961333229697 ()


  • Electroglottograph

N/A - 04961333229680

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

  • 04961333229680 ()


  • Electroglottograph

N/A - 04961333229628

Auditory Feedback Tools, Software
PENTAX OF AMERICA, INC.
3506
In Commercial Distribution

  • 04961333229628 ()
N/A

  • Electroglottograph

PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) - 04961333247417

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

  • 04961333247417 ()


  • Speech assistive training device

N/A - 04961333236589

COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device

PHONATORY AERODYNAMIC SYSTEM - 04961333236565

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

  • 04961333236565 ()


  • Electroglottograph

CAPE V - 04961333235421

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

  • 04961333235421 ()


  • Electroglottograph

Sleep Profiler - 00850015266706

Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser

Cytolink 1.0 Software DVD - 00849832011569

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

ADHEAR Configuration Software 1.0 DVD - 09008737522759

Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52275
Not in Commercial Distribution

  • 09008737522759 ()


  • Audiometric/hearing device software

ADHEAR Configuration Software 1.0 Download - 09008737382087

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

  • 09008737382087 ()


  • Audiometric/hearing device software

N/A - 00613994446060

SOFTWARE 9733877 STEALTHVIZ LINUX
MEDTRONIC NAVIGATION, INC.
9733877
In Commercial Distribution

  • 00613994446060 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994446053

SOFTWARE 9733878 STEALTHVIZ WIN32
MEDTRONIC NAVIGATION, INC.
9733878
In Commercial Distribution

  • 00613994446053 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994445988

SOFTWARE 9733760 CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733760
In Commercial Distribution

  • 00613994445988 ()


  • Neurological stereotactic surgery system

N/A - 07613327616118

Spine Guidance 5 Software
Stryker Leibinger GmbH & Co. KG
6002-810-000
In Commercial Distribution

  • 07613327616118 ()
6002-810-000

  • Optical surgical navigation device tracking system

Unitron - 07613389483895

Aura:fit Software v 5.0
Unitron Hearing Division
058-5260
In Commercial Distribution

  • 07613389483895 ()
058-5260

  • Audiometric/hearing device software

Unitron - 07613389483888

TrueFit Software v 5.0
Unitron Hearing Division
058-5259
In Commercial Distribution

  • 07613389483888 ()
058-5259

  • Audiometric/hearing device software

Scopis - 07613327514179

ENT Software with TGS
Stryker Leibinger GmbH & Co. KG
8000-021-002
In Commercial Distribution

  • 07613327514179 ()
8000-021-002

  • Stereotactic system application software

SPINEMAP - 07613327359954

SPINEMAP¿ 3D 3.1 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-680-000
In Commercial Distribution

  • 07613327359954 ()
6002-680-000

  • Surgical planning/navigation-enhancement system

GEMS Mobile ECG - 00812324000297

GEMS Mobile ECG software
CardioComm Solutions, Inc
GM
In Commercial Distribution

  • 00812324000297 ()
GM

  • Electrocardiograph, home-use

CD TrueFit Software v5.3 - 07613389638875

CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software

CHRONO-LOG - 00811476011670

vW CoFactor Opti8 Software
CHRONO-LOG CORP
vW CoFactor Opti8 Software
In Commercial Distribution

  • 00811476011670 ()


  • Platelet aggregation analyser IVD

CHRONO-LOG - 00811476011663

AGGRO/LINK Opti8 Software
CHRONO-LOG CORP
AGGRO/LINK Opti8 Software
In Commercial Distribution

  • 00811476011663 ()


  • Platelet aggregation analyser IVD

CHRONO-LOG - 00811476011007

AGGRO/LINK WBA Software
CHRONO-LOG CORP
AGGRO/LINK WBA Software
In Commercial Distribution

  • 00811476011007 ()


  • Platelet aggregation analyser IVD

PROFESS - 07613327286755

PROFESS(TM) SOFTWARE ENABLE
Stryker Leibinger GmbH & Co. KG
6001-400-300
In Commercial Distribution

  • 07613327286755 ()
6001-400-300

  • Robotic surgical navigation system application software

NA - 07613327115048

FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software

SPINEMAP - 07613327114898

SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software

Matrix Holter System - 90815187020399

M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020382

M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder

CS OMS Imaging Software - 60889971546975

CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971546975 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software - 60889971746849

CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971746849 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software

CS Orthodontic Imaging Software - 60889971746832

CS Orthodontic Imaging Software
CARESTREAM HEALTH, INC.
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60889971746832 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software - 60192156851666

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software - 60192156851659

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851659 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software

CS Orthodontic Imaging Software - 60192156851642

CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software
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