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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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GammaPod™ Treatment Control System - 00850002615012

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

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software

Merlin.net™ - 05415067047311

Merlin.net Software
ST. JUDE MEDICAL, INC.
MN7000
In Commercial Distribution

  • 05415067047311 ()
MN7000

  • Transtelephonic implantable pacemaker analysis system

EnSite Precision™ - 05415067046802

Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software

EnSite Precision™ - 05415067046185

Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software

NA - 05415067040404

MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system

EnSite™ - 05415067038098

Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software

EnSite™ - 05415067037763

Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application 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

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 9.0 - 09008737370367

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

  • 09008737370367 ()


  • 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

EncoreBasic - 00606959052406

EncoreBasic Software
Respironics, Inc.
2.12
In Commercial Distribution

  • 00606959052406 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959049284

EncoreBasic Software
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049284 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959046962

EncoreBasic Software
Respironics, Inc.
EncoreBasic Software - 2
In Commercial Distribution

  • 00606959046962 ()
1068689

  • Medical equipment clinical data interfacing software

Mammotome - 00841911101833

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

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Hearing Help Express - 00858177007236

Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set

QuantaFlo - 00859433006123

Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph

Lumipulse G ROMA - 00869164000017

Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD

TrackX - 00860099000837

TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software

Natus - 05713315008672

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

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer
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