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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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NuVEIW - 00860001554502

The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Designed for mobility and simplicity it will compete with entry level mobile carts. The NuVIEW® product is comprised of Mechanical and Hardware design inputs.
Cv Medical, LLC
NuVIEW
In Commercial Distribution

  • 00860001554502 ()


  • Medical image management system

Promaxo MRI System - 00860006901127

Magnetic Resonance Imaging System, Auxiliary Rack
Promaxo, Inc.
PR071-001-R
In Commercial Distribution

  • 00860006901127 ()
PR071-001-R

  • Full-body MRI system, permanent magnet

Promaxo MRI System - 00860006901110

Magnetic Resonance Imaging System, Magnet Cart
Promaxo, Inc.
PR071-001-M
In Commercial Distribution

  • 00860006901110 ()
PR071-001-M

  • Full-body MRI system, permanent magnet

SENSINEL™ CPM WEARABLE - 00860006382322

No Description
Analog Devices, Inc.
ADCP1100-WB-001
In Commercial Distribution

  • 00860006382322 ()


  • Wearable multiple vital physiological parameter monitoring system

SENSINEL™ CPM REPLACEMENT ADHESIVE PAD - 00860006382308

No Description
Analog Devices, Inc.
ADI-CS-200-001
In Commercial Distribution

  • 00860006382308 ()


  • Wearable multiple vital physiological parameter monitoring system

SENSINEL™ CPM ALIGNMENT TOOL - 00860006382346

No Description
Analog Devices, Inc.
ADCP1100-AT-001
In Commercial Distribution

  • 00860006382346 ()


  • Wearable multiple vital physiological parameter monitoring system

SENSINEL™ CPM BASE STATION - 00860006382339

No Description
Analog Devices, Inc.
ADCP-1100-BS-001
In Commercial Distribution

  • 00860006382339 ()


  • Wearable multiple vital physiological parameter monitoring system

SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) - 00860006382315

No Description
Analog Devices, Inc.
ADCP1100-PL-001
In Commercial Distribution

  • 00860006382315 ()


  • Wearable multiple vital physiological parameter monitoring system

See-Mode Technologies - 00860006305727

Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software

See-Mode Technologies - 00860006305703

Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software
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