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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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AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system
North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system
AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution

  • 00857042007128 ()
800407

  • Cardiac mapping system
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
ASPECT IMAGING LTD
Embrace
In Commercial Distribution

  • 00858755006309 ()
70007000

  • Full-body MRI system, permanent magnet
No Description
HAPPY HEALTH, INC.
Happy Ring HR1401GB
In Commercial Distribution

  • 00850068747177 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR1301GB
In Commercial Distribution

  • 00850068747160 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR1201GB
In Commercial Distribution

  • 00850068747153 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR1101GB
In Commercial Distribution

  • 00850068747146 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR1001GB
In Commercial Distribution

  • 00850068747139 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR0901GB
In Commercial Distribution

  • 00850068747122 ()


  • Multiple vital physiological parameter monitoring system, home-use
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