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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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Accessories of Intraoral Camera
Dentall co.,Ltd.
IOC-USB Cable
In Commercial Distribution

  • 08800096901036 ()


  • Intraoral camera
Intraoral Camera
Dentall co.,Ltd.
Camstar- handpiece
In Commercial Distribution

  • 08800096901029 ()


  • Intraoral camera
Intraoral Camera
Dentall co.,Ltd.
Camstar-Regular kit
In Commercial Distribution

  • 08800096901012 ()


  • Intraoral camera
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
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900089 ()
1.0

  • Dental treatment application software
Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900003 ()
1.0

  • Dental treatment application software
ABP ONTRAK MONITOR, BRAZIL, 90227
SPACELABS HEALTHCARE (WASHINGTON), INC
OnTrak
In Commercial Distribution

  • 10841522131431 ()
90227-8

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129629 ()

  • 38-50 cm OD
  • 15-20 in OD
016-0109-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129612 ()

  • 32-42 cm OD
  • 13-17 in OD
016-0077-07Q

  • Blood pressure ambulatory recorder
CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129605 ()

  • 12-20 cm OD
  • 5-8 in. OD
015-0118-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129599 ()
015-0068-07Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129582 ()

  • 17-26 cm OD
  • 7-10 in. OD
015-0067-06Q

  • Blood pressure ambulatory recorder
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
No Description
SUNTECH MEDICAL, INC.
98-0234-01
Not in Commercial Distribution

  • 10840935102779 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0125-04
In Commercial Distribution

  • 10840935102472 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0125-03
In Commercial Distribution

  • 10840935102465 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0124-04
In Commercial Distribution

  • 10840935102441 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0124-03
In Commercial Distribution

  • 10840935102434 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0123-04
In Commercial Distribution

  • 10840935102410 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0123-03
In Commercial Distribution

  • 10840935102403 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0122-04
In Commercial Distribution

  • 10840935102380 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0122-03
In Commercial Distribution

  • 10840935102373 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-88
In Commercial Distribution

  • 10840935101178 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-87
In Commercial Distribution

  • 10840935101161 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-86
In Commercial Distribution

  • 10840935101154 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-18
In Commercial Distribution

  • 10840935101147 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-17
In Commercial Distribution

  • 10840935101130 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-16
In Commercial Distribution

  • 10840935101123 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-15
In Commercial Distribution

  • 10840935101116 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-14
In Commercial Distribution

  • 10840935101109 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-13
In Commercial Distribution

  • 10840935101093 ()


  • Blood pressure ambulatory recorder
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