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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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Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution

  • 07613327538328 ()
81-81042

  • Electromagnetic/optical surgical navigation device tracking system
Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution

  • 07613327538410 ()
6000-670-300

  • Electromagnetic/optical surgical navigation device tracking system
No Description
Orthosoft Inc
20-8060-400-01
In Commercial Distribution

  • 00887868525681 ()
20-8060-400-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software
No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD
Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.
Aktina Corp.
80-800
In Commercial Distribution

  • B3658080000 ()


  • Accelerator system quality assurance device
No Description
Aktina Corp.
50-135
In Commercial Distribution

  • B365501350 ()


  • Stereotactic system application software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0010
Not in Commercial Distribution

  • 00815686021085 ()
SFT-0010

  • Virtual bronchoscopic navigation PACS software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0004
Not in Commercial Distribution

  • 00815686021061 ()
SFT-0004

  • Electromagnetic surgical navigation device tracking system
No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation
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