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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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NEUROWORKS/SLEEPWORKS 8.1.1 DVD (US)
XLTEK
015606
In Commercial Distribution

  • 00382830042147 ()


  • Electroencephalograph
Neuroworks Sleepworks 6.1 DVD  
XLTEK
005523
In Commercial Distribution

  • 00382830041898 ()


  • Electroencephalograph
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
Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display
No Description
Sugarmate, LLC
1008182
In Commercial Distribution

  • 00850018992626 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution

  • 00850018992619 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008180
In Commercial Distribution

  • 00850018992602 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
Electrode junction box (256 channel)
NIHON KOHDEN CORPORATION
JE-120A-24
In Commercial Distribution

  • 04931921108734 ()
JE-120A-24

  • Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN CORPORATION
JE-120A-23
In Commercial Distribution

  • 04931921108727 ()
JE-120A-23

  • Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN CORPORATION
JE-120A-22
In Commercial Distribution

  • 04931921108710 ()
JE-120A-22

  • Electroencephalograph
Electrode junction box (64 channel)
NIHON KOHDEN CORPORATION
JE-120A
In Commercial Distribution

  • 04931921108703 ()
JE-120A-21

  • Electroencephalograph
EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-124A
In Commercial Distribution

  • 04931921108192 ()
QI-124A

  • Electroencephalograph
BASE UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-123A
In Commercial Distribution

  • 04931921108185 ()
QI-123A

  • Electroencephalograph
No Description
Vysioneer Inc.
2.1.2
In Commercial Distribution

  • 04719884900011 ()


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

  • 04056869973371 ()


  • Radiology DICOM image processing application software
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