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

  • 05415067014672 ()
MG1000

  • Cardiac mapping system
Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution

  • 05415067001863 ()
H700186

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
VL Mapping Catheter, Sensor Enabled
In Commercial Distribution

  • 05415067031471 ()
H702520

  • Electrical-only medical device connection adaptor, reusable
Software Upgrade
ST. JUDE MEDICAL, INC.
H900004
In Commercial Distribution

  • 05415067030733 ()
H900004

  • General-purpose ultrasound imaging system
Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD
Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer
Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set
Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph
NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system
Merlin.net Software
ST. JUDE MEDICAL, INC.
MN7000
In Commercial Distribution

  • 05415067047311 ()
MN7000

  • Transtelephonic implantable pacemaker analysis system
Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software
MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer
PC Software
ACON LABORATORIES, INC.
1.2.89
In Commercial Distribution

  • 00682607001118 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 00066714700155 ()
CADI

  • Radiology information system application software
ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution

  • M248ATLASSW1 ()
  • 10381780252658 ()


  • Neurological stereotactic surgery system
+ QBL Software
STRYKER CORPORATION
0894000005
In Commercial Distribution

  • 07613327622799 ()
0894-000-005

  • Electronic surgical sponge-counter
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