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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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GN Otometrics A/S - 05713315004032

No Description
Natus Medical Denmark ApS
Patient Signal Switch (grey)
Not in Commercial Distribution

  • 05713315004032 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000737

No Description
Natus Medical Denmark ApS
Patient Responder (Grey)
Not in Commercial Distribution

  • 05713315000737 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000720

No Description
Natus Medical Denmark ApS
Patient Responder (Blue)
Not in Commercial Distribution

  • 05713315000720 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000713

No Description
Natus Medical Denmark ApS
Patient Responder (Red)
Not in Commercial Distribution

  • 05713315000713 ()


  • Tone audiometer

GuidePro3D - 00864551000304

dental implant surgical guide software
GuidePro3D
1.0
In Commercial Distribution

  • 00864551000304 ()


  • Dental treatment application software

RealCloud HD1 - 00864058000326

HDTV intraoral camera
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000326 ()


  • Intraoral camera

FeetMe Monitor FTM-DK - 03760349820048

FeetMe Monitor Medical device corresponding to a pair of connected insoles Model FTM-DK and version PVT2
FEETME
PVT2
In Commercial Distribution

  • 03760349820086 ()
  • 03760349820048 ()

  • EU-36
  • EU-35
  • EU-37
  • EU-38
  • EU-39
  • EU-40
  • EU-41
  • EU-42
  • EU-43
  • EU-44
  • EU-45
  • EU-46


  • Pressure monitoring insole

ACTEON - 03760278267594

C50 camera and its single-use protective sheath is intended to visualize anatomical and pathological details that cannot be seen with the naked eye or with a mirror (thanks to its magnification) in DAYLIGHT or DAYLIGHT+ modes. These modes allow the dentist to show difference between "before" and "after" care, as well as pathology control and post-treatment. C50 does not provide a diagnostic. (Without fluorescence option)
SOPRO
C50 - INTRAORAL CAMERA D
In Commercial Distribution

  • 03760278267594 ()
S_C50_0009

  • Intraoral camera

HAWK - 08800017900025

Highest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation
DXM CO., LTD
HD
In Commercial Distribution

  • 08800017900025 ()


  • Intraoral camera

PXL - 00813557020243

PXL Intraoral Camera
Digital Doc LLC
PXL-1000
In Commercial Distribution

  • 00813557020243 ()
PXL-1000

  • Intraoral camera
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