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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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EncoreBasic - 00606959039667

EncoreBasic Software
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959039667 ()
1068689

  • Medical equipment clinical data interfacing software

SYMFIT 7.0 Package - 09008738515293

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
51529
In Commercial Distribution

  • 09008738515293 ()


  • Audiometric/hearing device software

SYMFIT 5.1 Software - 09008738508981

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
50898
Not in Commercial Distribution

  • 09008738508981 ()


  • Audiometric/hearing device software

MAESTRO 11 - 09008737983307

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
Not in Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software

SYMFIT 8.0 Download - 09008737531065

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
53106
In Commercial Distribution

  • 09008737531065 ()


  • Audiometric/hearing device software

SYMFIT 8.0 USB - 09008737525859

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52585
In Commercial Distribution

  • 09008737525859 ()


  • Audiometric/hearing device software

SYMFIT 8.0 DVD - 09008737525811

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52581
In Commercial Distribution

  • 09008737525811 ()


  • Audiometric/hearing device software

SYMFIT 8.0 Download - 09008737525033

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52503
In Commercial Distribution

  • 09008737525033 ()


  • Audiometric/hearing device software

MAESTRO System Software 10 - 09008737421724

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
42172
In Commercial Distribution

  • 09008737421724 ()


  • Audiometric/hearing device software

MAESTRO 9.0 USB Package - 09008737402914

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40291
In Commercial Distribution

  • 09008737402914 ()


  • Audiometric/hearing device software

MAESTRO 9.0 Download Package - 09008737402907

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40290
In Commercial Distribution

  • 09008737402907 ()


  • Audiometric/hearing device software

MAESTRO 8.0 USB - 09008737380649

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38064
In Commercial Distribution

  • 09008737380649 ()


  • Audiometric/hearing device software

MAESTRO 8.0 Download - 09008737380632

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38063
In Commercial Distribution

  • 09008737380632 ()


  • Audiometric/hearing device software

MAESTRO 8.0 CD - 09008737380625

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38062
In Commercial Distribution

  • 09008737380625 ()


  • Audiometric/hearing device software

MAESTRO 7.0 Download - 09008737368579

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36857
Not in Commercial Distribution

  • 09008737368579 ()


  • Audiometric/hearing device software

MAESTRO 8.0 - 09008737359362

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35936
In Commercial Distribution

  • 09008737359362 ()


  • Audiometric/hearing device software

MAESTRO 7.0 - 09008737353469

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35346
Not in Commercial Distribution

  • 09008737353469 ()


  • Audiometric/hearing device software

MAESTRO 6.0 - 09008737318628

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
31862
Not in Commercial Distribution

  • 09008737318628 ()


  • Audiometric/hearing device software

MAESTRO 9.0 - 09008737370367

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37036
In Commercial Distribution

  • 09008737370367 ()


  • Audiometric/hearing device software

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

Mammotome - 00841911101833

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Mammotome - 00841911100638

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
Version 6.2
In Commercial Distribution

  • 00841911100638 ()


  • Mammographic stereotactic biopsy system

Apollo Knee - 05056139245862

ApolloKnee Software
CORIN LTD
TKR.SS.0001
In Commercial Distribution

  • 05056139245862 ()


  • Robotic surgical arm system

VERSANT - 00630414000534

LiPAScan software
Siemens Healthcare Diagnostics Inc.
10492006
In Commercial Distribution

  • 00630414000534 ()
10492006

  • Laboratory instrument/analyser application software IVD

NASOMETER - 04961333247301

NASOMETER SOFTWARE
PENTAX OF AMERICA, INC.
6500
In Commercial Distribution

  • 04961333247301 ()


  • Speech assistive training device

N/A - 04961333229987

Games, Software
PENTAX OF AMERICA, INC.
5167B
In Commercial Distribution

  • 04961333229987 ()


  • Electroglottograph

SONA-MATCH - 04961333229772

Sona-Match, Software
PENTAX OF AMERICA, INC.
5127
In Commercial Distribution

  • 04961333229772 ()


  • Electroglottograph

MULTI-SPEECH - 04961333229642

Multi-Speech Software
PENTAX OF AMERICA, INC.
3700
In Commercial Distribution

  • 04961333229642 ()


  • Electroglottograph

TrackX - 00860099000837

TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software

GammaPod™ Treatment Control System - 00850002615012

TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software

GammaPod™ Treatment Planning System - 00850002615029

TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software

WorkMate™ Unity™ - 05415067035608

Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067035578

Software Installation
ST. JUDE MEDICAL, INC.
H800010
In Commercial Distribution

  • 05415067035578 ()
H800010

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067035561

Software Installation
ST. JUDE MEDICAL, INC.
H800011
In Commercial Distribution

  • 05415067035561 ()
H800011

  • Cardiac catheterization monitoring system

EnSite Precision™ - 05415067035004

Software Installation
ST. JUDE MEDICAL, INC.
H702701
In Commercial Distribution

  • 05415067035004 ()
H702701

  • Cardiac mapping system application software

EnSite Precision™ - 05415067030085

Software Installation
ST. JUDE MEDICAL, INC.
H702469-SW
In Commercial Distribution

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028181

Software Installation
ST. JUDE MEDICAL, INC.
H702517-T
In Commercial Distribution

  • 05415067028181 ()
H702517-T

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028174

Software Installation
ST. JUDE MEDICAL, INC.
H702517
In Commercial Distribution

  • 05415067028174 ()
H702517

  • Cardiac mapping system application software

FlexAbility™ Ablation Catheter, Sensor Enabled™ - 05415067026248

Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software

Advisor™ FL Mapping Catheter, Sensor Enabled™ - 05415067026231

Software Installation
ST. JUDE MEDICAL, INC.
H702507
In Commercial Distribution

  • 05415067026231 ()
H702507

  • Electrical-only medical device connection adaptor, reusable

MediGuide™ - 05415067014672

Software Installation
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067014672 ()
MG1000

  • Cardiac mapping system

EnSite™ - 05415067003027

Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software

EnSite™ - 05415067001863

Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution

  • 05415067001863 ()
H700186

  • Cardiac mapping system application software

Advisor™ - 05415067031471

Software Installation
ST. JUDE MEDICAL, INC.
VL Mapping Catheter, Sensor Enabled
In Commercial Distribution

  • 05415067031471 ()
H702520

  • Electrical-only medical device connection adaptor, reusable

ViewMate™ - 05415067030733

Software Upgrade
ST. JUDE MEDICAL, INC.
H900004
In Commercial Distribution

  • 05415067030733 ()
H900004

  • General-purpose ultrasound imaging system

EnSite™ - 05415067033185

Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software

Vave - 00850001977043

Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software

Lumipulse G ROMA - 00869164000017

Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD

Natus - 05713315008672

Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

Hearing Help Express - 00858177007236

Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set
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