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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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NuVaMap O.R. Calibration Sphere
Nuvasive, Inc.
8210347
In Commercial Distribution

  • 00887517695505 ()


  • Spinal rod bending system
No Description
HeYuan FandDing Medical Co Ltd
/
In Commercial Distribution

  • 06975640490006 ()
  • 06975640490013 ()


  • Rapid test/self-testing data interpretive/transfer/validation software IVD
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS-1000
In Commercial Distribution

  • 06970136030216 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS2000A
In Commercial Distribution

  • 06970136030100 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
MON 25000 MCL SMART 2.1 USA
MEDTRONIC, INC.
25000
Not in Commercial Distribution

  • 00763000305079 ()


  • Cardiac pulse generator reader, home-use
Recorder for ph capsule
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPR-3
In Commercial Distribution

  • 16946332804200 ()
  • 06946332804203 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible
pH capsule
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 16946332804170 ()
  • 06946332804173 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible
Data recorder
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPR-3
In Commercial Distribution

  • 06946332800649 ()
  • 16946332803159 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible
pH capsule, 1 pack
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 06946332800625 ()
  • 06946332800045 ()
  • 06946332800632 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible
The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. • Interferometry: records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value; • Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus; • NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value; • Fluorescein BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of the fluorescein in the patient’s eye (invasive) and without cone; • Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale; • Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry. All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
Shenzhen CERTAINN Technology Co., Ltd.
DEA
In Commercial Distribution

  • 06972039971641 ()


  • Meibomian gland camera/ophthalmic interferometer
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