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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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Sierra Summit 12 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190280-200
In Commercial Distribution

  • 00840067100097 ()


  • Electromyograph
Sierra Summit Base
CADWELL INDUSTRIES, INC.
190272-200
In Commercial Distribution

  • 00840067100035 ()


  • Electromyograph
Sierra Summit StimTroller Plus
CADWELL INDUSTRIES, INC.
190274-200
In Commercial Distribution

  • 00840067100011 ()


  • Electromyograph
Device for displaying surface EMG signal intensity from active electrodes
BIONIT LABS SRL
MU01-01
In Commercial Distribution

  • 08057971592739 ()
  • 08057971591053 ()


  • Electromyograph
BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature
BTS SPA
1.0
In Commercial Distribution

  • B179TMJ1 ()
  • B179TMJ ()
BTSEMB1BM

  • Electromyograph
Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
BTS SPA
2.0
In Commercial Distribution

  • B179THN1 ()
  • B179THN2 ()
BTSEMB1BM

  • Electromyograph
BTS OMNIsEMG is an instrument for the electromyographic surface analysis.
BTS SPA
1.0
In Commercial Distribution

  • B179OMN ()
BTSEMB1BM

  • Electromyograph
BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas. It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
BTS SPA
1000
In Commercial Distribution

  • B179FR11 ()
  • B179FR1 ()
BTSEMB1BM

  • Electromyograph
BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
BTS SPA
300
In Commercial Distribution

  • B179FE31 ()
  • B179FE3 ()
BTSFE3

  • Electromyograph
No Description
SUN NUCLEAR CORP.
TMM
In Commercial Distribution

  • B136411LE0 ()


  • Diagnostic ultrasound phantom, test object
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