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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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RALS - 00850049633048

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.5
In Commercial Distribution

  • 00850049633048 ()
7.1.5

  • Medical equipment clinical data interfacing software

RALS - 00850049633031

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.2
In Commercial Distribution

  • 00850049633031 ()
7.1.2

  • Medical equipment clinical data interfacing software

RALS - 00850049633024

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.1
In Commercial Distribution

  • 00850049633024 ()
7.1.1

  • Medical equipment clinical data interfacing software

RALS - 00850049633017

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
6.0 SP9 Patch 2
In Commercial Distribution

  • 00850049633017 ()
6.0 SP9 Patch 2

  • Medical equipment clinical data interfacing software

RALS - 00850049633000

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.4
In Commercial Distribution

  • 00850049633000 ()
7.1.4

  • Medical equipment clinical data interfacing software

BD FACSuite - 00382906630032

BD FACSuite™ Clinical Flow Cytometry Software v1.3
Becton, Dickinson And Company
663003
In Commercial Distribution

  • 00382906630032 ()
663003

  • Laboratory instrument/analyser application software IVD

FACS - 00382906577658

BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD

Natus - 00382830045070

EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph

Kosmos OTS Android Linear Color - 09353278000694

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Linear - 09353278000687

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software

EchoNous Samsung S8 Tablet with Software (Refurbished) - 09353278000670

EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
ECHONOUS, INC.
R007635
In Commercial Distribution

  • 09353278000670 ()


  • Hand-held ultrasound imaging system, body-surface

VolparaDensity - 09421904268098

VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.3
In Commercial Distribution

  • 09421904268098 ()


  • Radiology DICOM image processing application software

BioJet Target - 04260476810015

Software for biopsy needle guide planning and tracking.
Medical Targeting Technologies GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software

Care Orchestrator - 00606959056909

Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.22
In Commercial Distribution

  • 00606959056909 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959056329

Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.21
In Commercial Distribution

  • 00606959056329 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959056084

Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.20
In Commercial Distribution

  • 00606959056084 ()
1126366

  • Medical equipment clinical data interfacing software

Siesta - 09342451002112

Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder

Siesta - 09342451001788

Siesta 802 Basic PSG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic PSG System
In Commercial Distribution

  • 09342451001788 ()
9007-0060-00

  • Polysomnograph

Care Orchestrator - 00606959057760

Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.24
In Commercial Distribution

  • 00606959057760 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959057500

Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.23
In Commercial Distribution

  • 00606959057500 ()
1126366

  • Medical equipment clinical data interfacing software
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