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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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Trigno Avanti 12-inch Snap Lead EMG Sensor - 00851679007261

Trigno System Component
DELSYS, INC.
SP-W06-018B
In Commercial Distribution

  • 00851679007261 ()


  • Psychophysiological biofeedback system

Trigno Avanti Snap Lead EMG Sensor - 00851679007254

Trigno System Component
DELSYS, INC.
SP-W06-018A
In Commercial Distribution

  • 00851679007254 ()


  • Psychophysiological biofeedback system

Trigno Avanti Mini Sensor - 00851679007247

Trigno System Component
DELSYS, INC.
SP-W06-024
In Commercial Distribution

  • 00851679007247 ()


  • Psychophysiological biofeedback system

Trigno Quattro Sensor - 00851679007230

Trigno System Component
DELSYS, INC.
SP-W06-016
In Commercial Distribution

  • 00851679007230 ()


  • Psychophysiological biofeedback system

Trigno Galileo Sensor - 00851679007223

Trigno System Component
DELSYS, INC.
SP-W06-017
In Commercial Distribution

  • 00851679007223 ()


  • Psychophysiological biofeedback system

MasteRad - 00860001404753

MasteRad MX-30 Radiographic System
Medicatech Usa, Inc.
MasteRad MX30
In Commercial Distribution

  • 00860001404753 ()
MasteRad MX30

  • Stationary basic diagnostic x-ray system, digital

DR 400 - 05414904281321

No Description
AGFA
5520/150
In Commercial Distribution

  • 05414904281321 ()
MBFTK

  • Stationary basic diagnostic x-ray system, digital

Valory - 05414904275535

No Description
AGFA
5540/100
In Commercial Distribution

  • 05414904275535 ()
MAVV8

  • Stationary basic diagnostic x-ray system, digital

DR 600 - 05414904274330

DR with option for Tomosynthesis
AGFA
5530/100
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, digital

DR 400 - 05414904176252

DR 400 SYSTEM
AGFA
5520/100
In Commercial Distribution

  • 05414904176252 ()
51FS1

  • Stationary basic diagnostic x-ray system, digital

DX-D 400 - 05414904125571

DX-D 400 DIGITAL MANUAL (D)
AGFA
5420/101
In Commercial Distribution

  • 05414904125571 ()
5U68J

  • Stationary basic diagnostic x-ray system, digital

DX-D 600 - 05414904108802

DX-D 600 ANALOG MANUAL SYSTEM
AGFA
5430/050
In Commercial Distribution

  • 05414904108802 ()
5TJOG

  • Stationary basic diagnostic x-ray system, digital

DX-D 600 - 05414904092316

DX-D 600 AUTOMATIC SYSTEM
AGFA
5430/120
In Commercial Distribution

  • 05414904092316 ()
5R2ZT

  • Stationary basic diagnostic x-ray system, digital

DX-D 600 - 05414904092309

DX-D 600 SEMI-AUTOMATIC SYSTEM
AGFA
5430/110
In Commercial Distribution

  • 05414904092309 ()
5R2YR

  • Stationary basic diagnostic x-ray system, digital

DR 400 - 05414904217870

DR 400 5520/200 Automatic
AGFA
5520/200
In Commercial Distribution

  • 05414904217870 ()
58UCJ

  • Stationary basic diagnostic x-ray system, digital

DR 600 - 05414904197202

DR 600 SEMI-AUTOMATIC
AGFA
5530/200
In Commercial Distribution

  • 05414904197202 ()
542WK

  • Stationary basic diagnostic x-ray system, digital

DR 600 - 05414904196298

DR 600 FULLY AUTOMATIC
AGFA
5530/100
In Commercial Distribution

  • 05414904196298 ()
542VH

  • Stationary basic diagnostic x-ray system, digital

DX-D 600 - 05414904092293

DX-D 600 MANUAL SYSTEM
AGFA
5430/100
In Commercial Distribution

  • 05414904092293 ()
5R2XP

  • Stationary basic diagnostic x-ray system, digital

DX-D 400 - 05414904085714

DX-D 400 ANALOG MANUAL (D)
AGFA
5420/100
In Commercial Distribution

  • 05414904085714 ()
5RJ2R

  • Stationary basic diagnostic x-ray system, digital

DX-D 400 - 05414904085707

DX-D 400 ANALOG MANUAL
AGFA
5420/200
In Commercial Distribution

  • 05414904085707 ()
5RJ1P

  • Stationary basic diagnostic x-ray system, digital

DX-D 300 - 05414904079607

DX-D 300 MASTER CODE
AGFA
8207/050
In Commercial Distribution

  • 05414904079607 ()
5NBXP

  • Stationary basic diagnostic x-ray system, digital

Z-MOTION - 05999116186126

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság
8612
In Commercial Distribution

  • 05999116186126 ()


  • Stationary basic diagnostic x-ray system, digital

MiniCAT 2D - 00860290000377

The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
XORAN TECHNOLOGIES LLC
10030
In Commercial Distribution

  • 00860290000377 ()


  • Stationary basic diagnostic x-ray system, digital

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Axon - 09413000078459

EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078459 ()
100161

  • Psychophysiological biofeedback system

Axon - 09413000078442

Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000078442 ()
100160

  • Psychophysiological biofeedback system

Axon - 09413000078435

Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078435 ()
100140

  • Psychophysiological biofeedback system

Axon - 09413000078428

EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system
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