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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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N/Al - 04961333231157

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

  • 04961333231157 ()


  • Electroglottograph

N/A - 04961333229802

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

  • 04961333229802 ()


  • 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

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

NA - 04931921100783

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

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph

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

PlanIQ - 05060608880874

Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software

StealthStation® Cranial - 00643169625532

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system

WorkMate Claris™ - 05415067018090

Software Upgrade Kit v.F
ST. JUDE MEDICAL, INC.
H701809
In Commercial Distribution

  • 05415067018090 ()
H701809

  • Cardiac catheterization monitoring system

EnSite™ - 05415067032256

Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-CF-01
In Commercial Distribution

  • 05415067032256 ()
ENSITE-D-CF-01

  • Cardiac mapping system application software

EnSite™ - 05415067032249

Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-CF-01
In Commercial Distribution

  • 05415067032249 ()
ENSITE-CF-01

  • Cardiac mapping system application software

Advisor™ HD Grid Mapping Catheter - 05415067029256

Advisor HD Software Kit
ST. JUDE MEDICAL, INC.
H702519
In Commercial Distribution

  • 05415067029256 ()
H702519

  • Electrical-only medical device connection adaptor, reusable

EnSite Precision™ - 05415067026279

Software Installation, v.1.0.1
ST. JUDE MEDICAL, INC.
H702503
In Commercial Distribution

  • 05415067026279 ()
H702503

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software

AutoMark - 05415067026149

Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026125

Software Installation, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496
In Commercial Distribution

  • 05415067026125 ()
H702496

  • Cardiac mapping system application software

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

EnSite™ - 05414734219211

Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software

N/A - 00643169491830

SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system

Sleep Profiler - 00850015266706

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

  • 00850015266706 ()


  • Polysomnography analyser

FrameLink™ - 00643169363540

SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system

Nonin - 00849686072617

SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software

IMPAX - 05400874000727

IMPAX Software 6.X
Agfa HealthCare NV
6
In Commercial Distribution



  • Radiological PACS software

AptiVue™ - 05415067048882

Imaging Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1015209
In Commercial Distribution

  • 05415067048882 ()
1015209

  • Coronary optical coherence tomography system

Ultreon™ - 05415067047694

2.0 Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1015310
In Commercial Distribution

  • 05415067047694 ()
1015310

  • Coronary optical coherence tomography system

WorkMate™ Unity™ - 05415067047229

Software Upgrade, 10 Licenses
ST. JUDE MEDICAL, INC.
H800020
In Commercial Distribution

  • 05415067047229 ()
H800020

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067047205

Module Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800018
In Commercial Distribution

  • 05415067047205 ()
H800018

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067047199

Software Upgrade Site License
ST. JUDE MEDICAL, INC.
H800021
In Commercial Distribution

  • 05415067047199 ()
H800021

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067047182

Z620 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800016
In Commercial Distribution

  • 05415067047182 ()
H800016

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067047175

Z440 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800017
In Commercial Distribution

  • 05415067047175 ()
H800017

  • Cardiac catheterization monitoring system

EnSite™ - 05415067042460

EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0
In Commercial Distribution

  • 05415067042460 ()
ENSITE-SW-2.0

  • Cardiac mapping system application software

Respiratory Module - 05056190500733

Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system

N/A - 00613994776730

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

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable

N/A - 00613994596826

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

  • 00613994596826 ()


  • Neurological stereotactic surgery system

Baha - 09321502036023

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

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set

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

Baha - 09321502032834

Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
95430
In Commercial Distribution

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set

N/A - 00613994099488

SOFTWARE 9732811 MICROCAL PLUS
MEDTRONIC NAVIGATION, INC.
9732811
In Commercial Distribution

  • 00613994099488 ()


  • Multi-purpose stereotactic surgery system

AKUNAH REFLECT - 09309002093005

Akunah Reflect Planning Software
AKUNAH PTY LTD
REFLECT
In Commercial Distribution

  • 09309002093005 ()


  • Orthopaedic/craniofacial implantation planning software

ARVIS ® - 09309001071011

ARVIS Surgical Planning Software
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-27300
In Commercial Distribution

  • 09309001071011 ()


  • Orthopaedic/craniofacial implantation planning software

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

ADHEAR Configuration Software 1.0 USB - 09008737363635

Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36363
In Commercial Distribution

  • 09008737363635 ()


  • Audiometric/hearing device software

iConnect Access - 00842000100683

Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000100683 ()


  • Radiology picture archiving and communication system workstation
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