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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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CEREC Software Version 5.1.0 Licence
SIRONA Dental Systems GmbH
6732361
In Commercial Distribution

  • E26767323610 ()


  • CAD/CAM software
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
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738820 ()
019.2033

  • Dental milling system, CAD/CAM, chairside
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738813 ()
019.2032

  • Dental milling system, CAD/CAM, laboratory
No Description
Orthosoft Inc
20-8060-400-01
In Commercial Distribution

  • 00887868525681 ()
20-8060-400-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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
Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution

  • 07613327538328 ()
81-81042

  • Electromagnetic/optical surgical navigation device tracking system
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
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