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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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3000SPORT-E-125 F-Scan Sensor
Tekscan, Inc.
3000SPORT-E-125 F-Scan Sensor
In Commercial Distribution

  • B9703000SPORTE1250 ()
3000SPORT-E-125

  • Body-surface pressure mapping system
3000-E-S F-Scan Sensor
Tekscan, Inc.
3000-E-S F-Scan Sensor
In Commercial Distribution

  • B9703000ES0 ()
3000-E-S

  • Body-surface pressure mapping system
3000-E-50 F-Scan Sensor
Tekscan, Inc.
3000-E-50 F-Scan Sensor
In Commercial Distribution

  • B9703000E500 ()
3000-E-50

  • Body-surface pressure mapping system
3000-E-125 F-Scan Sensor
Tekscan, Inc.
3000-E-125 F-Scan Sensor
In Commercial Distribution

  • B9703000E1250 ()
3000-E-125

  • Body-surface pressure mapping system
Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular blood pressure monitor
Blackbox Remote Patient Monitoring LLC
BPM-103C
In Commercial Distribution

  • B963103C0 ()
  • B963BB10BPM103C10 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular Blood Pressure monitor
Blackbox Remote Patient Monitoring LLC
BPM-102C
In Commercial Distribution

  • B963102C1 ()
  • B963BB10BPM102C10 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular Blood Pressure Monitor
Blackbox Remote Patient Monitoring LLC
BPM-101C
In Commercial Distribution

  • B963101C1 ()
  • BB1BB963101C1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Velacur ONE is an ultrasound medical device used to provide estimates of tissue stiffness, ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.
Sonic Incytes Medical Corp.
LI-1100
In Commercial Distribution

  • B995LI11000 ()
LI1100

  • Hepatic ultrasound elastography system
Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system
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