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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
AMPLIVOX LIMITED
Otowave 102-C
In Commercial Distribution

  • 05060488902635 ()


  • Vestibulo-auditory analysis system
No Description
AMPLIVOX LIMITED
Model 270+
In Commercial Distribution

  • 05060488901645 ()


  • Vestibulo-auditory analysis system
No Description
AMPLIVOX LIMITED
Otosure
In Commercial Distribution

  • 05060488901409 ()


  • Vestibulo-auditory analysis system
No Description
AMPLIVOX LIMITED
PC850
In Commercial Distribution

  • 05060488901157 ()


  • Vestibulo-auditory analysis system
An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will be powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.
GM INSTRUMENTS LIMITED
NR6
In Commercial Distribution

  • 05060485270034 ()
N/A

  • Computerized rhinomanometer
Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with 4 load cells mounted between them. The vertical component of the total reaction force is measured independent of where it is applied over the surface of the plates. The relative light weight and small geometry of the plates aids in a wide range of upper and lower limb applications. The ForcePlates measure as little as the touch of a finger through to full standing weight bearing. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.
BIOMETRICS LIMITED
FP3
In Commercial Distribution

  • 05060481690089 ()


  • Posturography system platform
A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.
OPTOS PUBLIC LIMITED COMPANY
P200TxE
In Commercial Distribution

  • 05057056107509 ()

  • Depth: 570 Millimeter
  • Width: 540 Millimeter
  • Height: 683 Millimeter
A10750

  • Scanning-laser ophthalmoscope/retinal optical coherence tomography system
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc. The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions. It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
OPTOS PUBLIC LIMITED COMPANY
P200TE
In Commercial Distribution

  • 05057056107004 ()
A10700

  • Scanning-laser ophthalmoscope/retinal optical coherence tomography system
No Description
OPTOS PUBLIC LIMITED COMPANY
A10688
In Commercial Distribution

  • 05057056106885 ()


  • Scanning-laser retinal imaging system
No Description
OPTOS PUBLIC LIMITED COMPANY
P200DTx
In Commercial Distribution

  • 05057056106502 ()
A10650

  • Scanning-laser retinal imaging system
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