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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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No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution



  • Tone audiometer
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
The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) Showing the difference between “before” and “after” care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).
SOPRO
C50 - INTRAORAL CAMERA
In Commercial Distribution

  • 03760278267587 ()
S_C50_0008

  • Intraoral camera
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

  • 03760278267037 ()
  • 03760278267020 ()
S_C50_0002

  • Intraoral camera
No Description
FEETME
PVT3
In Commercial Distribution

  • 03760349820093 ()
  • 03760349820055 ()
  • 03760349820048 ()


  • Pressure monitoring insole
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
Medical device corresponding to a pair of connected insoles model FTM-DK, version PVT1
FEETME
PVT1
In Commercial Distribution

  • 03760349820000 ()
  • 03760349820079 ()

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


  • Pressure monitoring insole
No Description
AIOBIO CO.,LTD
Qraypen
In Commercial Distribution

  • 08800043200038 ()


  • Intraoral camera
No Description
SUNTECH MEDICAL, INC.
98-0234-03
Not in Commercial Distribution

  • 10840935102793 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0234-02
Not in Commercial Distribution

  • 10840935102786 ()


  • Blood pressure ambulatory recorder
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