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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Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
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
UDI Software Pristina
GE MEDICAL SYSTEMS
PRISTINA 2.8.3
In Commercial Distribution

  • 00195278711229 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
No Description
WAL-MART STORES, INC.
HTD8813C
In Commercial Distribution

  • 10194346520470 ()
  • 00194346520473 ()
HTD8815US

  • Infrared patient thermometer, skin
No Description
WAL-MART STORES, INC.
HTD8813C
In Commercial Distribution

  • 10194346458032 ()
  • 00194346458035 ()
  • 20194346458039 ()
HTD8815US

  • Infrared patient thermometer, skin
No Description
Siemens Healthcare GmbH
11549431
In Commercial Distribution

  • 04056869978741 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11605361
In Commercial Distribution

  • 04056869973180 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11594780
In Commercial Distribution

  • 04056869962801 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11330003
In Commercial Distribution

  • 04056869263168 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11330002
In Commercial Distribution

  • 04056869231051 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11330001
In Commercial Distribution

  • 04056869231044 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10267000
In Commercial Distribution

  • 04056869152684 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11061640
In Commercial Distribution

  • 04056869151571 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11061620
In Commercial Distribution

  • 04056869051314 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11061610
In Commercial Distribution

  • 04056869051291 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10849000
In Commercial Distribution

  • 04056869046877 ()


  • Stationary angiographic x-ray system, digital
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11007962
In Commercial Distribution

  • 04056869044798 ()


  • SPECT/CT system
No Description
Siemens Healthcare GmbH
11060606
In Commercial Distribution

  • 04056869014012 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10890594
In Commercial Distribution

  • 04056869014005 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060605
In Commercial Distribution

  • 04056869013992 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060602
In Commercial Distribution

  • 04056869013978 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060607
In Commercial Distribution

  • 04056869013961 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060601
In Commercial Distribution

  • 04056869013954 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060600
In Commercial Distribution

  • 04056869013947 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060599
In Commercial Distribution

  • 04056869013930 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060597
In Commercial Distribution

  • 04056869013923 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060596
In Commercial Distribution

  • 04056869013916 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060598
In Commercial Distribution

  • 04056869013909 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060591
In Commercial Distribution

  • 04056869013893 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060594
In Commercial Distribution

  • 04056869013886 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060592
In Commercial Distribution

  • 04056869013879 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060595
In Commercial Distribution

  • 04056869013862 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
11060593
In Commercial Distribution

  • 04056869013855 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10046789
In Commercial Distribution

  • 04056869013114 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10830856
In Commercial Distribution

  • 04056869013077 ()


  • Radiation therapy software
No Description
Siemens Healthcare GmbH
10046798
In Commercial Distribution

  • 04056869013060 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10046799
In Commercial Distribution

  • 04056869013053 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10046734
In Commercial Distribution

  • 04056869013046 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10046733
In Commercial Distribution

  • 04056869013039 ()


  • Full-body CT system
No Description
Siemens Healthcare GmbH
10092614
In Commercial Distribution

  • 04056869011578 ()


  • Manual-aperture-control diagnostic x-ray system collimator, motorized
No Description
Siemens Healthcare GmbH
10590100
In Commercial Distribution

  • 04056869011011 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10891666
In Commercial Distribution

  • 04056869010342 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10495568
In Commercial Distribution

  • 04056869010335 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10967888
In Commercial Distribution

  • 04056869010328 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10967666
In Commercial Distribution

  • 04056869010311 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10165977
Not in Commercial Distribution

  • 04056869010304 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10165888
Not in Commercial Distribution

  • 04056869010298 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10165566
In Commercial Distribution

  • 04056869010281 ()


  • Full-body CT system
No Description
Siemens Shanghai Medical Equipment Ltd.
10045692
In Commercial Distribution

  • 04056869010274 ()


  • Full-body CT system
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007642
In Commercial Distribution

  • 04056869010205 ()


  • Cardiac catheterization laboratory computer
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