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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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Natus - 00382830045070

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

  • 00382830045070 ()


  • Electromyograph

Leica Biosystems CytoVision FISH review software (inc. dongle) - 00849832004318

Leica Biosystems CytoVision FISH review software (inc. dongle)
Leica Biosystems Richmond, Inc.
23SWR000FXX001
Not in Commercial Distribution

  • 00849832004318 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision FISH Software License Activation Code - 00849832004301

Leica Biosystems CytoVision FISH Software License Activition Code
Leica Biosystems Richmond, Inc.
23SWR000FLX001
Not in Commercial Distribution

  • 00849832004301 ()

  • Device Size Text, specify:


  • Microscope objective

Leica Biosystems CytoVision CGH Software License Activation Code - 00849832004288

Leica Biosystems CytoVision CGH Software License Activation Code
Leica Biosystems Richmond, Inc.
23SWR000CGX001
Not in Commercial Distribution

  • 00849832004288 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

N/A - 04961333230358

Vocal Parts and Vocal Pathology I & II Software
PENTAX OF AMERICA, INC.
9225
In Commercial Distribution

  • 04961333230358 ()


  • Electroglottograph

N/A - 04961333229871

Applied Speech Science for Voice & Resonance Disorders, Software
PENTAX OF AMERICA, INC.
5156
Not in Commercial Distribution

  • 04961333229871 ()


  • Electroglottograph

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

BioJet Target - 04260476810015

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

  • 04260476810015 ()


  • Brachytherapy system application software

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

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

Nihon Kohden SVM-7200 Series Vital Signs Monitor - 04931921006054

Software Kit for SVM-7200 Series Vital Signs Monitor
NIHON KOHDEN CORPORATION
QS-126P
In Commercial Distribution

  • 04931921006054 ()
QS-126P

  • General-purpose multi-parameter bedside monitor

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

GeoSource - 00863003000343

Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
ELECTRICAL GEODESICS, INC.
GeoSource 2.0
Not in Commercial Distribution

  • 00863003000343 ()


  • Electroencephalograph

Gimmi - 04049047653516

ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system

APNEICARE CONNECTION CENTER/INTERNET ANALYSIS - G642CC1A0

Medical software used for oximetry analysis and reporting.
APNEICARE, LLC
CCIA
In Commercial Distribution

  • G642CC1A0 ()


  • Medical equipment clinical data interfacing software
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