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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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Manipolo di Stimolazione Elettrica 2+ - 08056446900284

Electrical Stimulation Probe for EMG/EP systems
EB NEURO SPA
B9700068100
In Commercial Distribution

  • 08056446900284 ()


  • Electromyograph

Manipolo di Stimolazione Elettrica - 08056446900277

Electrical Stimulation Probe for EMG/EP systems
EB NEURO SPA
B9700068000
In Commercial Distribution

  • 08056446900277 ()


  • Electromyograph

Myo Unit - 08057971591053

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

  • 08057971592739 ()
  • 08057971591053 ()


  • Electromyograph

TMJOINT - B179TMJ

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

TEETHAN - B179THN2

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

OMNIsEMG - B179OMN

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

  • B179OMN ()
BTSEMB1BM

  • Electromyograph

FREEEMG - B179FR1

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

FREEEMG - B179FE3

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

PillCam - 07290110361167

PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software

PillCam - 07290110360795

PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software
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