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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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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
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
468BHP
In Commercial Distribution

  • B136468BHP0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
468BH
In Commercial Distribution

  • B136468BH0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
467
In Commercial Distribution

  • B1364670 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
464
In Commercial Distribution

  • B1364640 ()


  • CT phantom, test object
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