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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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Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Bookwalter® Retractor Set, Anterior Lumbar Spinalhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
SYMMETRY SURGICAL INC.
50-5740
In Commercial Distribution

  • 00887482172339 ()
50-5740

  • Surgical retractor/retraction system blade, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=edit&deviceRecordKey=30865#
Aaren Scientific Inc.
EC-3
In Commercial Distribution

  • 00884872015894 ()


  • Posterior-chamber intraocular lens, pseudophakic
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Videahealth, Inc.
VCA01B
Not in Commercial Distribution

  • 00196852162192 ()


  • Dental x-ray image interpretive software
No Description
Velmeni Inc.
1.0
In Commercial Distribution

  • 00860010893203 ()
V4D

  • Dental x-ray image interpretive software
Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Videahealth, Inc.
VDA01BPN
In Commercial Distribution

  • 00860009836822 ()


  • Dental x-ray image interpretive software
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
Videahealth, Inc.
VPA01BP
In Commercial Distribution

  • 00860009836815 ()


  • Dental x-ray image interpretive software
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Videahealth, Inc.
VCA01B
In Commercial Distribution

  • 00860009836808 ()


  • Dental x-ray image interpretive software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586363 ()


  • Dental x-ray image interpretive software
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