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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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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

FONA CDR DICOM - D764B10351060

FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software

BioPlex 2200 - 03610520540633

BioPlex 2200 System Operation Manual , Software Version 4.3
BIO-RAD LABORATORIES, INC.
SW Version 4.3
In Commercial Distribution

  • 03610520540633 ()

  • 1 EA
12000958

  • Fluorescent immunoassay analyser IVD, laboratory

BioPlex 2200 - 03610520505915

BioPlex 2200 System Operation Manual , Software Version 4.2
BIO-RAD LABORATORIES, INC.
SW Version 4.2
In Commercial Distribution

  • 03610520505915 ()

  • 1 EA
6600813-4.2.1

  • Fluorescent immunoassay analyser IVD, laboratory

LABSYSTEM™ PRO - 08714729884002

LABSYSTEM™ PRO EP Review Workstation Software, V2.7
BOSTON SCIENTIFIC CORPORATION
M00420020300
In Commercial Distribution

  • 08714729884002 ()


  • Cardiopulmonary physiological parameter analysis software
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