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

  • 00851679007247 ()


  • Psychophysiological biofeedback system
Trigno System Component
DELSYS, INC.
SP-W06-016
In Commercial Distribution

  • 00851679007230 ()


  • Psychophysiological biofeedback system
Trigno System Component
DELSYS, INC.
SP-W06-017
In Commercial Distribution

  • 00851679007223 ()


  • Psychophysiological biofeedback system
MasteRad MX-30 Radiographic System
Medicatech Usa, Inc.
MasteRad MX30
In Commercial Distribution

  • 00860001404753 ()
MasteRad MX30

  • Stationary basic diagnostic x-ray system, digital
Stationary Xray System
Swissray Medical AG
ddR Formula Plus
In Commercial Distribution

  • 00860011334620 ()


  • Stationary basic diagnostic x-ray system, digital
Stationary Xray System
Swissray Medical AG
ddR Element
In Commercial Distribution

  • 00860011334613 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
XORAN TECHNOLOGIES LLC
10031
In Commercial Distribution

  • 00860008443748 ()


  • Stationary basic diagnostic x-ray system, digital
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
10035
In Commercial Distribution

  • 00860008443724 ()


  • Stationary basic diagnostic x-ray system, digital
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
X-Ray System, General Purpose Podiatry
SOURCE-RAY, INC.
PXS-710D
In Commercial Distribution

  • 00868162000296 ()
900100

  • Stationary basic diagnostic x-ray system, digital
No Description
GE MEDICAL SYSTEMS, INC.
5000
In Commercial Distribution

  • 00840682104364 ()


  • Stationary basic diagnostic x-ray system, digital
Kangaroo NTrainer Handpiece
Cardinal Health 200, LLC
1000NT-H
In Commercial Distribution

  • 10885380198786 ()
1000NT-H

  • Psychophysiological biofeedback system
NTrainer System 2.0
Cardinal Health 200, LLC
1000NT
In Commercial Distribution

  • 10885380195587 ()
1000NT

  • Psychophysiological biofeedback system
XR646 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR646
In Commercial Distribution

  • 00840682115339 ()


  • Stationary basic diagnostic x-ray system, digital
XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital
Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital
XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00840682136709 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
GE Hualun Medical Systems Co., Ltd
5896002
Not in Commercial Distribution

  • 00840682125871 ()


  • Stationary basic diagnostic x-ray system, digital
G3 RAD Elevation Table
GE Hualun Medical Systems Co., Ltd
9999966
In Commercial Distribution

  • 00840682125864 ()


  • Stationary basic diagnostic x-ray system, digital
Everest III EXT WS
GE Hualun Medical Systems Co., Ltd
5896000
In Commercial Distribution

  • 00840682125857 ()


  • Stationary basic diagnostic x-ray system, digital
Chogori Standard Table
GE Hualun Medical Systems Co., Ltd
6788888
In Commercial Distribution

  • 00840682123839 ()


  • Stationary basic diagnostic x-ray system, digital
iFlashPad 17x17 inch 100um detector
GE Hualun Medical Systems Co., Ltd
4343
In Commercial Distribution

  • 00840682121071 ()


  • Stationary basic diagnostic x-ray system, digital
Pioneer DR Cabinet
GE Hualun Medical Systems Co., Ltd
XR385
In Commercial Distribution

  • 00840682118149 ()


  • Stationary basic diagnostic x-ray system, digital
G2 RAD Elevation Table
GE Hualun Medical Systems Co., Ltd
6999999
In Commercial Distribution

  • 00840682117906 ()


  • Stationary basic diagnostic x-ray system, digital
Digital X-Ray Sensor
BIOKINEMETRICS, INC.
IMA-4600
In Commercial Distribution

  • 10862318000311 ()


  • Stationary basic diagnostic x-ray system, digital
XR656 G1 SYS-CABINET WSO
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682146210 ()


  • Stationary basic diagnostic x-ray system, digital
Manual Wallstand
GE Hualun Medical Systems Co., Ltd
GCMWS-C5
In Commercial Distribution

  • 00840682145978 ()


  • Stationary basic diagnostic x-ray system, digital
Optima XR646 HD System
GE Hualun Medical Systems Co., Ltd
XR646 HD
In Commercial Distribution

  • 00840682142175 ()


  • Stationary basic diagnostic x-ray system, digital
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00840682142168 ()


  • Stationary basic diagnostic x-ray system, digital
G3 Standard Table
GE Hualun Medical Systems Co., Ltd
6788888-2
In Commercial Distribution

  • 00840682141932 ()


  • Stationary basic diagnostic x-ray system, digital
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