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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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STarFix™ Designer Laptop, 1x
FHC, INC.
C0267-00917
In Commercial Distribution

  • 00873263009178 ()
C0267

  • Stereotactic neuronavigation/planning system
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363619 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution

  • 04260521363534 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363527 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.0
In Commercial Distribution

  • 04260521363510 ()


  • CAD/CAM software
  • Dental milling system, CAD/CAM, chairside
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution

  • 03760408001005 ()


  • Pathology information system
Ai-Rad Companion Organs RT About Box
Siemens Healthcare GmbH
11545290
In Commercial Distribution

  • 04056869274645 ()


  • Radiology DICOM image processing application software
  • Radiological PACS software
No Description
Siemens Healthcare GmbH
11665508
In Commercial Distribution

  • 04056869973371 ()


  • Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11665278
Not in Commercial Distribution

  • 04056869955667 ()


  • Radiology DICOM image processing application software
MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278560384 ()
5919805

  • CT system application software
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