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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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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

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

N/A - 04961333229871

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

  • 04961333229871 ()


  • Electroglottograph

N/A - 04961333230358

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

  • 04961333230358 ()


  • Electroglottograph

Diagnostix™ - 00634782075941

PC Software for Digital BP,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6023NPC
In Commercial Distribution

  • 00634782075941 ()
6023NPC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Diagnostix™ - 00634782058470

PC Software for BP Unit,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6017PC
Not in Commercial Distribution

  • 00634782058470 ()
6017PC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

OMNIBotics - 00841690194019

Software unitary component (common to hip and knee)
Omni Life Science, Inc.
TOOL 14-020
In Commercial Distribution

  • 00841690194019 ()
TOOL 14-020

  • Robotic surgical navigation system application software
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