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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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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 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™ CPM WEARABLE - 00860006382322

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

  • 00860006382322 ()


  • 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

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

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

FIRMM® - 00860004785101

Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution

  • 00860004785101 ()

  • Length: 155 Millimeter
  • Width: 65 Millimeter
  • Height: 206 Millimeter
FIRMM®

  • MRI system application software

ANNE Chest - 00860004541745

The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
810-00012
In Commercial Distribution

  • 00860004541745 ()


  • Wearable multiple vital physiological parameter monitor
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