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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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iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006179 ()
700-49000-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution

  • 00860479001706 ()
Z2000

  • Corneal topography system
  • Automated ophthalmic refractometer
No Description
Brainlab AG
18097
In Commercial Distribution

  • 04056481004958 ()
  • 04056481006525 ()
  • 04056481004965 ()
18097

  • Robotic surgical navigation system
  • Intracranial catheter navigation transmitter stylet
The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
CENTERVUE SPA
RETIA 2
In Commercial Distribution

  • 08053677040086 ()
AINEUME002

  • Ophthalmic fundus camera
  • Scanning-laser retinal imaging system
No Description
LUNEAU TECHNOLOGY OPERATIONS
VISUREF 1000
In Commercial Distribution

  • 03664188000589 ()


  • Multiple ocular dimension meter
  • Ophthalmic fundus camera
No Description
LUNEAU TECHNOLOGY OPERATIONS
DNEye Scanner 3
In Commercial Distribution

  • 03664188000404 ()


  • Multiple ocular dimension meter
  • Ophthalmic fundus camera
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 800
In Commercial Distribution

  • 04049471096026 ()

  • Weight: 33 Kilogram
  • Total height (including head rest) 1390 mm (plus 300 mm lift)
  • Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
  • Utility space of instrument table (W x D) 1060 mm x 420 mm


  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 600
In Commercial Distribution

  • 04049471096019 ()

  • Weight: 33 Kilogram
  • Total height (including head rest) 1390 mm (plus 300 mm lift)
  • Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
  • Utility space of instrument table (W x D) 1060 mm x 420 mm


  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution

  • 07290016986099 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
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