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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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No Description
BTL INDUSTRIES LIMITED
EMTONE
In Commercial Distribution

  • B108784POEMTENUS0100 ()


  • Multi-modality hyperthermia system
No Description
BTL INDUSTRIES LIMITED
BTL-703
In Commercial Distribution

  • B108703POENUS0100 ()


  • Multi-modality hyperthermia system
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
No Description
PURE LIFE SOLUTIONS INC.
ABP-U80R
Not in Commercial Distribution

  • B459SY18200 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular enabled blood pressure monitor
Vital Health Links LLC
LS802GP
In Commercial Distribution

  • G122LS802GP0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
No Description
IDEA HEALTH LLC
ID-BP808
In Commercial Distribution

  • G057IDBP8081 ()
  • G057IDBP8080 ()
  • G057IDBP8082 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic.
Instrumentation Difra SA
VisioBox II
In Commercial Distribution

  • B516221860 ()
22186

  • Dynamic visual acuity testing system
The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic.
Instrumentation Difra SA
VisioBox II
In Commercial Distribution

  • B51622186 ()
22186

  • Dynamic visual acuity testing system
ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
DORSAVI LTD
000VMPLU0
In Commercial Distribution

  • B758000VMPLU0 ()
VMPLU

  • Psychophysiological biofeedback system
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