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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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Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients.
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070045 ()
GAS0045

  • Whole-body plethysmograph
Fluid Status Monitor
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070014 ()
GAS0035

  • Whole-body plethysmograph
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00763000292553 ()


  • Cerebrospinal fluid shunt valve programmer
moorLDLS-BI - Laser Doppler Line Scanner, Burns Imaging System
MOOR INSTRUMENTS LIMITED
moorLDLS-BI
In Commercial Distribution

  • 15060484490089 ()


  • Cutaneous microcirculation laser Doppler imaging device
moorLDI2-BI - Laser Doppler Imager, Burns Imaging System
MOOR INSTRUMENTS LIMITED
moorLDI2-BI
In Commercial Distribution

  • 15060484490072 ()


  • Cutaneous microcirculation laser Doppler imaging device
moorLDLS - Laser Doppler Line Scanner
MOOR INSTRUMENTS LIMITED
moorLDLS
In Commercial Distribution

  • 15060484490065 ()


  • Cutaneous microcirculation laser Doppler imaging device
moorLDI2 - Laser Doppler Imager (>= S/N 5700)
MOOR INSTRUMENTS LIMITED
moorLDI2
In Commercial Distribution

  • 15060484490058 ()


  • Cutaneous microcirculation laser Doppler imaging device
moorFLPI2 - Full-Field Laser Perfusion Imager
MOOR INSTRUMENTS LIMITED
moorFLPI2
In Commercial Distribution

  • 15060484490041 ()


  • Cutaneous microcirculation laser Doppler imaging device
moorMVS-OXY - Tissue Oxygen and Temperature Monitor
MOOR INSTRUMENTS LIMITED
moorVMS-OXY
In Commercial Distribution

  • 15060484490027 ()


  • Tissue saturation oximeter
moorVMS-PRES - Pressure Cuff Controller
MOOR INSTRUMENTS LIMITED
moorVMS-PRES
In Commercial Distribution

  • 15060484490010 ()


  • Laser Doppler blood flowmeter
moorVMS-LDF - Laser Doppler Perfusion and Temperature Monitor
MOOR INSTRUMENTS LIMITED
moorVMS-LDF
In Commercial Distribution

  • 15060484490003 ()


  • Laser Doppler blood flowmeter
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
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
The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing. Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device, and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture.
Shenzhen CERTAINN Technology Co., Ltd.
easyRef
In Commercial Distribution

  • 06972039971573 ()


  • Automated ophthalmic refractometer
The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.
Shenzhen CERTAINN Technology Co., Ltd.
iRef
In Commercial Distribution

  • 06972039971542 ()


  • Hand-held subjective ophthalmic refractometer
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of the eye visible. There is also a range of accessories available for the Slit Lamp to allow special diagnosis possibilities in addition to the general examinations. A camera may be attached to the slit lamp to take photographs of different parts of the eye.
Shenzhen CERTAINN Technology Co., Ltd.
SL-M6
In Commercial Distribution

  • 06972039971405 ()


  • Ophthalmic examination slit lamp
Apex Locator
J.MORITA MFG.CORP.
RCM-7
In Commercial Distribution

  • 00887919758013 ()
5025412U0

  • Endodontic apex locator
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go 120K
In Commercial Distribution

  • 17290013587869 ()
  • 07290013587862 ()
  • 27290013587866 ()
7290013587862

  • Cosmetic red-light phototherapy system, home-use
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