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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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OBM ROLL STAND KIT
XLTEK
OBM00003
In Commercial Distribution

  • 00382830008020 ()


  • Electroencephalograph
BASE UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-123A
In Commercial Distribution

  • 04931921108185 ()
QI-123A

  • Electroencephalograph
No Description
Vysioneer Inc.
2.1.2
In Commercial Distribution

  • 04719884900011 ()


  • Radiology DICOM image processing application software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software
No Description
Bigfoot Biomedical, Inc.
SW-300983
In Commercial Distribution

  • 00850003506517 ()
SW-300983

  • Self-care monitoring/reporting software
Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display
Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Electrode junction box (256 channel)
NIHON KOHDEN CORPORATION
JE-120A-24
In Commercial Distribution

  • 04931921108734 ()
JE-120A-24

  • Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN CORPORATION
JE-120A-23
In Commercial Distribution

  • 04931921108727 ()
JE-120A-23

  • Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN CORPORATION
JE-120A-22
In Commercial Distribution

  • 04931921108710 ()
JE-120A-22

  • Electroencephalograph
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