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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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Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software
MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation software
EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software
FLUOROMAP 1.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6006-600-000
In Commercial Distribution

  • 07613252286578 ()
6006-600-000

  • Robotic surgical navigation system application software
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system
Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital
Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
8.0
In Commercial Distribution

  • 00810106410845 ()
987957

  • Radiation therapy software
vW CoFactor Software
CHRONO-LOG CORP
vW CoFactor Software
In Commercial Distribution

  • 00811476011045 ()


  • Platelet aggregation analyser IVD
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