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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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BD FACSDiva - 00382906595232

BD FACSDiva™ Software
BECTON, DICKINSON AND COMPANY
659523
Not in Commercial Distribution

  • 00382906595232 ()
659523

  • Laboratory instrument/analyser application software IVD

BD Multiset™ - 00382903431168

Simulset Version 3.1 Software
BECTON, DICKINSON AND COMPANY
343116
Not in Commercial Distribution

  • 00382903431168 ()
343116

  • Laboratory instrument/analyser application software IVD

BD FACSComp™ - 00382903431151

FACSComp Version 4.0 Software
BECTON, DICKINSON AND COMPANY
343115
Not in Commercial Distribution

  • 00382903431151 ()
343115

  • Laboratory instrument/analyser application software IVD

TRUST - 08809965590005

TRUST Dental CAD Software
Rgorithm Korea
V1.0
In Commercial Distribution

  • 08809965590005 ()


  • CAD/CAM software

Xltek - 00382830043458

RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software

Natus - 00382830039475

SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph

Natus - 00382830038034

Synergy Application Software v20.0
NATUS NEUROLOGY INCORPORATED
482-645500
In Commercial Distribution

  • 00382830038034 ()


  • Electromyograph

Natus - 00382830038003

Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph

Natus - 00382830061957

Natus Elite Software - Viking
NATUS NEUROLOGY INCORPORATED
033416
In Commercial Distribution

  • 00382830061957 ()


  • Electromyograph

Natus - 00382830061940

Natus Elite Software - Synergy
NATUS NEUROLOGY INCORPORATED
033415
In Commercial Distribution

  • 00382830061940 ()


  • Electromyograph

Keypoint - 00382830050302

Review Software (Single User)
NATUS MANUFACTURING LIMITED
9033S0628
In Commercial Distribution

  • 00382830050302 ()
9033S0628

  • Electromyograph

Embla - 00382830048484

RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive 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

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

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

Baha - 09321502032834

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

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set

Baha - 09321502026383

Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set

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

Baha - 09321502036023

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

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set

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

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

Omnilab Direct - 00606959044296

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

  • 00606959044296 ()
1113127

  • Clinical laboratory information system

HL7 - 00606959039049

HL7 Forwarding Service Software
Respironics, Inc.
Software, HL7 Forwarding Service - 3
In Commercial Distribution

  • 00606959039049 ()
1104880

  • Clinical laboratory information system

Sleepware - 00606959039001

Sleepware G3 Software, Web
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959039001 ()
1115720

  • Polysomnography analyser

Omnilab Direct - 00606959038769

Software, OmniLab Direct, Web
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959038769 ()
1113127

  • Ventilator IMV controller

DirectView - 00606959028630

DirectView Software Version 2.4
Respironics, Inc.
DirectView PC Software Application, Web - 2
In Commercial Distribution

  • 00606959028630 ()
1063558

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959052239

Care Orchestrator Software, Netherlands
Respironics, Inc.
1.14
In Commercial Distribution

  • 00606959052239 ()
1136535

  • Medical equipment clinical data interfacing software

Sleepware - 00606959045262

Software, Sleepware G3 (Multi-Lingual)
Respironics, Inc.
Sleepware G3 Software, Multi-Lingual - 3
In Commercial Distribution

  • 00606959045262 ()
1082463

  • Polysomnography analyser

Sleepware - 00606959045255

Software, Sleepware G3 (EN)
Respironics, Inc.
Sleepware G3 Software, English - 3
In Commercial Distribution

  • 00606959045255 ()
1082462

  • Polysomnography analyser

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

N/A - 00613994596826

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

  • 00613994596826 ()


  • Neurological stereotactic surgery system

N/A - 00613994776730

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

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable

Messenger - 00865190000304

Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software

EnsoSleep - 00864458000407

Automated sleep scoring software.
ENSODATA, INC.
01.1
Not in Commercial Distribution

  • 00864458000407 ()


  • Sleep disorder interpretive software, professional-only
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