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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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The Via X Anti-Gravity Treadmill is intended to be a used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support.
Lifeward CA, Inc.
Via X
In Commercial Distribution

  • 00850022788031 ()


  • Pneumatic-support treadmill
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
Lifeward CA, Inc.
Fit X
In Commercial Distribution

  • 00850022788017 ()


  • Pneumatic-support treadmill
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
Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution

  • 00860009233577 ()
  • 00860009233539 ()
TC21NXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Whoop, Inc.
1.x
In Commercial Distribution

  • 00860012964819 ()


  • Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution

  • 00860135001934 ()


  • Electronic acoustic stethoscope
No Description
SCIMAGE, INC
3.x
In Commercial Distribution

  • 00861917000305 ()


  • Radiological PACS software
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