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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
DÜRR DENTAL SE
J2713
In Commercial Distribution

  • E247J27131 ()


  • Intraoral camera
No Description
DÜRR DENTAL SE
J2712
In Commercial Distribution

  • E247J27121 ()


  • Intraoral camera
No Description
DÜRR DENTAL SE
J2711
In Commercial Distribution

  • E247J27111 ()


  • Intraoral camera
No Description
DÜRR DENTAL SE
J2110
In Commercial Distribution

  • E247J21101 ()


  • 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
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
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
No Description
SUNTECH MEDICAL, INC.
98-0068-12
In Commercial Distribution

  • 10840935101086 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0068-11
In Commercial Distribution

  • 10840935101079 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0063-14
In Commercial Distribution

  • 10840935101062 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0063-13
In Commercial Distribution

  • 10840935101055 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0063-12
In Commercial Distribution

  • 10840935101048 ()


  • Blood pressure ambulatory recorder
No Description
SUNTECH MEDICAL, INC.
98-0063-11
In Commercial Distribution

  • 10840935101031 ()


  • Blood pressure ambulatory recorder
ABP ULTRALITE MONITOR, MULTI-LINGUAL, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultralite
In Commercial Distribution

  • 10841522108341 ()
R-90217A-1

  • Blood pressure ambulatory recorder
Blood Pressure Long-Term Ambulatory Recorder
SPACELABS HEALTHCARE (WASHINGTON), INC
90207
Not in Commercial Distribution

  • 10841522106675 ()
N/A

  • Blood pressure ambulatory recorder
Ambulatory Blood Pressure Monitor
SPACELABS HEALTHCARE (WASHINGTON), INC
90217
Not in Commercial Distribution

  • 10841522105074 ()
N/A

  • Blood pressure ambulatory recorder
ABP ULTRALITE MONITOR,MULTI-LINGUAL
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultralite
In Commercial Distribution

  • 10841522105067 ()
90217A-1

  • 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

  • 10841522129261 ()

  • 38-50 cm OD
  • 15-20 in. OD
016-0109-05Q

  • 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

  • 10841522129254 ()

  • 32 cm-42 cm ID
016-0077-06Q

  • Blood pressure ambulatory recorder
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