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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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Straight Arm System - 00817100020018

Universal Radiographic Straight Arm system variable focal distance left loading Only.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000
In Commercial Distribution

  • 00817100020018 ()


  • Stationary basic diagnostic x-ray system, digital

Prism - 07290019736004

No Description
GRAYMATTERS HEALTH LTD
1.0
In Commercial Distribution

  • 07290019736004 ()


  • Psychophysiological biofeedback system

OMNERA 500A - 07350008750098

Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
Precision i5
In Commercial Distribution

  • 07350008750098 ()


  • Stationary basic diagnostic x-ray system, digital

OMNERA 400T - 07350008750050

Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital

OMNERA 400A - 07350008750012

Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution

  • 07350008750012 ()


  • Stationary basic diagnostic x-ray system, digital

uDR - 00810030350071

The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
UIH TECHNOLOGIES LLC
uDR 780i
In Commercial Distribution

  • 00810030350071 ()


  • Stationary basic diagnostic x-ray system, digital

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

eVu Senz App iOS - 07540191000623

No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system

Vaginal Pressure Probe - 07540191000616

No Description
Thought Technology Ltd.
SA9005
In Commercial Distribution

  • 07540191000616 ()


  • Psychophysiological biofeedback system

Pressure Sensor - 07540191000609

No Description
Thought Technology Ltd.
SA9003
In Commercial Distribution

  • 07540191000609 ()


  • Psychophysiological biofeedback system
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