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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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RING/BAR ELECTRODE SWITCH BOX
CADWELL INDUSTRIES, INC.
190292-200
In Commercial Distribution

  • 00840067100264 ()


  • Electromyograph
Cascade Pro 16Ch Amplifier
CADWELL INDUSTRIES, INC.
190265-200
In Commercial Distribution

  • 00840067100189 ()


  • Electromyograph
Sierra Ascent 2 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190275-200
In Commercial Distribution

  • 00840067100141 ()


  • Electromyograph
Sierra Ascent Base
CADWELL INDUSTRIES, INC.
190273-200
In Commercial Distribution

  • 00840067100134 ()


  • Electromyograph
HDA280 Sennheiser Headphone
CADWELL INDUSTRIES, INC.
199268-200
Not in Commercial Distribution

  • 00840067100127 ()


  • Electromyograph
Summit Tendon Hammer
CADWELL INDUSTRIES, INC.
190282-200
In Commercial Distribution

  • 00840067100110 ()


  • Electromyograph
Sierra Summit 2 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190276-200
In Commercial Distribution

  • 00840067100103 ()


  • Electromyograph
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
Richmar EMG Software
COMPASS HEALTH BRANDS CORP.
EMG-SW
In Commercial Distribution

  • 00092237626573 ()


  • 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
No Description
SUN NUCLEAR CORP.
403GSLE
In Commercial Distribution

  • B136403GSLE0 ()


  • Diagnostic ultrasound phantom, test object
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
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3015
In Commercial Distribution

  • 00810117211141 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
35-2-1
In Commercial Distribution

  • 00810117211134 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-01
In Commercial Distribution

  • 00810117211127 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-05Z
In Commercial Distribution

  • 00810117211110 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3239-1
In Commercial Distribution

  • 00810117210090 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3239
In Commercial Distribution

  • 00810117210076 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3241
In Commercial Distribution

  • 00810117210069 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-010
In Commercial Distribution

  • 00810117210052 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-050
In Commercial Distribution

  • 00810117210045 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3209-2
In Commercial Distribution

  • 00810117210038 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3209
In Commercial Distribution

  • 00810117210021 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A1946
In Commercial Distribution

  • 00810117210014 ()


  • Nuclear medicine phantom, point source
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG HeadBox Kit
In Commercial Distribution

  • 27290114060817 ()
750-020013-00

  • Electromyograph
SW upgrade, v8.0 US
Given Imaging, Inc.
FGS-0541
In Commercial Distribution

  • 07290101365273 ()


  • Video capsule endoscopy system application software
SW upgrade, v8.0 SCA
Given Imaging, Inc.
FGS-0479-01
In Commercial Distribution

  • 07290101365006 ()


  • Video capsule endoscopy system application software
SW kit, v8.3 US WS
Given Imaging, Inc.
FGS-0525
In Commercial Distribution

  • 07290101364870 ()


  • Video capsule endoscopy system application software
SW kit, v8.3 US
Given Imaging, Inc.
FGS-0523
In Commercial Distribution

  • 07290101364856 ()


  • Video capsule endoscopy system application software
WS, Dell T3400, SCA
Given Imaging, Inc.
FGS-0487
In Commercial Distribution

  • 07290101364207 ()


  • Video capsule endoscopy system application software
RT SW kit, v8.0 WW
Given Imaging, Inc.
FGS-0472
In Commercial Distribution

  • 07290101363477 ()


  • Video capsule endoscopy system application software
Access SW kit, v7.0 WS
Given Imaging, Inc.
FGS-0434
Not in Commercial Distribution

  • 07290101362784 ()


  • Video capsule endoscopy system application software
Access SW kit, v7.0
Given Imaging, Inc.
FGS-0396
In Commercial Distribution

  • 07290101362265 ()


  • Video capsule endoscopy system application software
SW upgrade, v7.0
Given Imaging, Inc.
FGS-0399
In Commercial Distribution

  • 07290101362234 ()


  • Video capsule endoscopy system application software
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