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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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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
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
Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution

  • 00823073061019 ()

  • Height: 244 Centimeter
  • Stand and Detector Head
  • Weight: 875 Kilogram


  • Stationary basic diagnostic x-ray system, digital
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
No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system
Digital Medical X-ray Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i
In Commercial Distribution

  • 06971576833023 ()


  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)
SAGE PRODUCTS, LLC
9101
In Commercial Distribution

  • 50618029850596 ()
  • 00618029850591 ()
9101

  • Dry medical towel/wipe, single-use
  • Skin cleaning wipe
FRAXEL FTX CONSOLE, NEXT GENERATION
SOLTA MEDICAL
MCSYSFTX
In Commercial Distribution

  • 00816995027805 ()
MCSYSFTX

  • Dermatological laser beam guiding handpiece
  • Dermatological solid-state laser system
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