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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 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

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 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 Alpha - 04056869153490

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

  • 04056869153490 ()


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

Orthex - 00841731118844

Orthex P&C Software v1.2
VILEX IN TENNESSEE, INC.
ORTHEXRPS
In Commercial Distribution

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software

KARL STORZ SCB - 04048551060599

KARL STORZ SCB Software Upgrade
Karl Storz GmbH & Co. KG
20090001-28
In Commercial Distribution

  • 04048551060599 ()


  • Operating room audiovisual data/device management system application software

n.a. - 04048551325117

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001S432
In Commercial Distribution

  • 04048551325117 ()


  • Operating room audiovisual data/device management system

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

n.a. - 04048551329856

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-44
In Commercial Distribution

  • 04048551329856 ()


  • Operating room audiovisual data/device management system application software

IH-Com V5.2 - 03610522123919

IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
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