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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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EnSite™ - 05415067033185

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

  • 05415067033185 ()
H702601

  • 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 Precision™ - 05415067030085

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

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software

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

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

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

Sunrise - 05430001896015

Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750382

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

Diopsys® - 00850514007091

NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system

Natus - 05713315008672

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

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

Cadi - 10667147001559

Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001559 ()
CADI

  • Radiology information system application software

Mammotome - 00841911100638

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

  • 00841911100638 ()


  • Mammographic stereotactic biopsy system

MedNet - 10887787001751

Metnet Software
HOSPIRA, INC.
6.20.01
In Commercial Distribution

  • 10887787001751 ()
160376404

  • Infusion pump medication-dosage application software

Arial - 00840948100840

Arial Software
Securitas Healthcare LLC
54302
In Commercial Distribution

  • 00840948100840 ()


  • Alarm application software

Bionic Navigator™ 3D - 00191506007546

4.1 Software
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-410
In Commercial Distribution

  • 00191506007546 ()


  • Implantable electrical stimulation device management software

Mammotome - 00841911101833

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

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

ICU Medical MedNet - 10887787009139

Mednet Software
ICU MEDICAL, INC.
6.31.01
In Commercial Distribution

  • 10887787009139 ()
160379202

  • Infusion pump medication-dosage application software
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