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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 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006643 ()
700-49002-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006636 ()
700-49001-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006629 ()
700-49000-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006308 ()
700-48586-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
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
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
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
No Description
LUNEAU TECHNOLOGY OPERATIONS
VISUREF 1000
In Commercial Distribution

  • 03664188000589 ()


  • Multiple ocular dimension meter
  • Ophthalmic fundus camera
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