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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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ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution

  • 10190302017756 ()


  • Human genomic analysis interpretive software
SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator.
SKANRAY TECHNOLOGIES LIMITED
303-000018-16
In Commercial Distribution

  • 08904269403683 ()


  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000051 ()
MXU-RV71

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000044 ()
MXU-RV60

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000037 ()
MXU-RV35

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000013 ()
MXU-RV19

  • Mobile basic diagnostic x-ray system, digital
X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital
The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
ILLUMINA, INC.
20032573
In Commercial Distribution

  • 00816270020217 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
The uDR 596i Radiographic system is intended to be used 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, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue
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
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