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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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Cios Flow - 04056869246628

mobile C-arm; software version VA31A
Siemens Healthcare GmbH
11108110
In Commercial Distribution

  • 04056869246628 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Spin - 04056869153506

mobile C-arm; software version VA30
Siemens Healthcare GmbH
10308194
In Commercial Distribution

  • 04056869153506 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Alpha - 04056869153490

mobile C-arm; software version VA31A
Siemens Healthcare GmbH
11105200
In Commercial Distribution

  • 04056869153490 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

CIOS SELECT - 04056869267197

mobile C-arm; software version VA21
Siemens Shanghai Medical Equipment Ltd.
11515055
In Commercial Distribution

  • 04056869267197 ()


  • Portable general-purpose fluoroscopic x-ray system, analogue

Smartdop XT6 - 00894912002968

Bidirectional Doppler with Smart-XT-Link6 software
KOVEN TECHNOLOGY, INC.
Smartdop XT6
In Commercial Distribution

  • 00894912002968 ()
Smartdop XT6

  • Noninvasive vascular ultrasound system, line-powered

not applicable - 00195278655141

Software Pristina 8.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.2
In Commercial Distribution

  • 00195278655141 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

not applicable - 00195278560049

Software Pristina 8.1 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8
In Commercial Distribution

  • 00195278560049 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

not applicable - 00195278866899

Software Pristina 8.4 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.6
In Commercial Distribution

  • 00195278866899 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

not applicable - 00195278795724

Software Pristina 8.3 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.4
In Commercial Distribution

  • 00195278795724 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

not applicable - 00195278716026

UDI Software Pristina ME 9.1
GE MEDICAL SYSTEMS
PRISTINA ME 9.1
In Commercial Distribution

  • 00195278716026 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
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