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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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CONTOUR® DIABETES APP - 00301933536018

Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software

GLUCOFACTS® DELUXE - 00301933515013

Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software

CADstream - 00842000101178

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6
In Commercial Distribution

  • 00842000101178 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000101116

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000101116 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000101031

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.4
In Commercial Distribution

  • 00842000101031 ()


  • Radiology picture archiving and communication system workstation

NA - 00841983101298

Exercise test software
NIHON KOHDEN AMERICA, INC.
QP-156E
Not in Commercial Distribution

  • 00841983101298 ()
QP-156E

  • Electrocardiograph, professional, multichannel

NA - 00841983101274

Digital video software
NIHON KOHDEN AMERICA, INC.
QP-110AK
In Commercial Distribution

  • 00841983101274 ()
QP-110AK

  • Electroencephalograph

Merge Cardio - 00842000100928

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
12.1
In Commercial Distribution

  • 00842000100928 ()


  • Radiological PACS software

Merge OrthoTemplates - 00842000100904

Software implant template
MERGE HEALTHCARE SOLUTIONS INC.
40.2.2
In Commercial Distribution

  • 00842000100904 ()


  • Surgical implant template, reusable

CADstream - 00842000100881

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100881 ()


  • Radiology picture archiving and communication system workstation

eFilm Lite - 00842000100867

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.3
Not in Commercial Distribution

  • 00842000100867 ()


  • Radiological PACS software

eFilm Workstation - 00842000100850

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.3
Not in Commercial Distribution

  • 00842000100850 ()


  • Radiological PACS software

CADstream - 00842000100638

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.2
In Commercial Distribution

  • 00842000100638 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100607

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.1.0
In Commercial Distribution

  • 00842000100607 ()


  • Radiological PACS software

Merge Cardio - 00842000100591

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100591 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100584

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.4
Not in Commercial Distribution

  • 00842000100584 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100577

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100577 ()


  • Radiological PACS software

Merge PACS - 00842000100560

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100560 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100553

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.1 Patch 1
Not in Commercial Distribution

  • 00842000100553 ()


  • Radiological PACS software

Merge PACS - 00842000100508

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100508 ()


  • Radiological PACS software

Merge Cardio - 00842000100416

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100416 ()


  • Radiology picture archiving and communication system workstation

Merge OrthoPACS - 00842000100348

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100348 ()


  • Radiological PACS software

Merge Unity PACS - 00842000100331

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.2
In Commercial Distribution

  • 00842000100331 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100317

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.3
Not in Commercial Distribution

  • 00842000100317 ()


  • Radiological PACS software

eFilm Lite - 00842000100294

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100294 ()


  • Radiological PACS software

eFilm Workstation - 00842000100287

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100287 ()


  • Radiological PACS software

Merge iConnect Access - 00842000100126

Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100126 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100096

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.2
Not in Commercial Distribution

  • 00842000100096 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100089

Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
7.1.1
In Commercial Distribution

  • 00842000100089 ()


  • Radiological PACS software

Merge PACS - 00842000100072

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.1.1
In Commercial Distribution

  • 00842000100072 ()


  • Radiological PACS software

Merge Unity PACS - 00842000100058

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.1.2
In Commercial Distribution

  • 00842000100058 ()


  • Radiological PACS software

Merge Cardio - 00842000100041

Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100041 ()


  • Radiological PACS software

MAXUM - M737M61021

Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system

IntelliVue XDS Software - 00884838059313

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838059313 ()
867019

  • Bedside information system application software

Welch Allyn, Inc. - 00732094312812

Software ELI LINK
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094312812 ()
107347

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094272352

Q-STRESS SOFTWARE V4.60
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272352 ()
11090-001-50

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094128482

PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel

IntelliVue XDS Software - 00884838123175

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software

Affinti 70 Diaagnostic Ultrasound System Circular Edition - 00884838114258

Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system

Affinti 50 Diaagnostic Ultrasound System Circular Edition - 00884838114241

Software Version 10.0.2
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838114241 ()


  • General-purpose ultrasound imaging system

EPIQ 5W Diagnostic Ultrasound System - 00884838114128

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system

EPIQ 5 Diagnostic Ultrasound System - 00884838114111

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system

IntelliVue XDS Software - 00884838109957

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838109957 ()
867019

  • Bedside information system application software

AlignRT Plus - 05056190500818

AlignRT 6.2 software
VISION RT LIMITED
AlignRT 6.2
Not in Commercial Distribution

  • 05056190500818 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500689

AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500320

AlignRT 6.1 software
VISION RT LIMITED
AlignRT 6.1
Not in Commercial Distribution

  • 05056190500320 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500177

AlignRT 6.0 software
VISION RT LIMITED
AlignRT 6.0
Not in Commercial Distribution

  • 05056190500177 ()


  • Radiological video camera patient positioning/tracking system

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

JointVue 3D Echo - 00850014885007

3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software

FilmQA Pro - 00850000065000

Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
7.0
In Commercial Distribution

  • 00850000065000 ()
N/A

  • Radiation therapy software
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