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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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Analog Devices, Inc.
ADCP1100-WB-001
In Commercial Distribution

  • 00860006382322 ()


  • Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADCP1100-PL-001
In Commercial Distribution

  • 00860006382315 ()


  • Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADI-CS-200-001
In Commercial Distribution

  • 00860006382308 ()


  • Wearable multiple vital physiological parameter monitoring system
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
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
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
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SpineAR
In Commercial Distribution

  • 00860003884126 ()


  • Surgical planning/navigation-enhancement system
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SyncAR
In Commercial Distribution

  • 00860003884102 ()


  • Surgical planning/navigation-enhancement system
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
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
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