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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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Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094225938 ()
RV100-B

  • Ophthalmic fundus camera
Topcon TRC-NW400 Non-Mydriatic Retinal Desktop Camera, use with RetinaVue Network. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
Not in Commercial Distribution

  • 00732094223873 ()
723427

  • Ophthalmic fundus camera
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution

  • 00860011850908 ()


  • Cognitive assessment software
The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only.
Oivi AS
OFC100L
In Commercial Distribution

  • 00860010826812 ()


  • Ophthalmic fundus camera
No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution

  • 00860009693401 ()


  • Cognitive assessment software
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution

  • 00860009484504 ()


  • Cognitive assessment software
BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution

  • 00860011042105 ()


  • Cognitive assessment software
A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution

  • 00860009958104 ()


  • Cognitive assessment software
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Optain Health, Inc.
Resolve Fundus Camera
In Commercial Distribution

  • 00860014304507 ()


  • Ophthalmic fundus camera
No Description
RETIVUE, LLC
WFP-B-G1.5-0A
In Commercial Distribution

  • 00860011978305 ()


  • Ophthalmic fundus camera
DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
41177
In Commercial Distribution

  • 00851434007024 ()


  • Ophthalmic fundus camera
DigiSIght Technologies Inc. Paxos Scope Ophthalmic Camera with optional 20D acrylic lens
DIGISIGHT TECHNOLOGIES, INC.
40807
In Commercial Distribution

  • 00851434007017 ()


  • Ophthalmic fundus camera
DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
40806
In Commercial Distribution

  • 00851434007000 ()


  • Ophthalmic fundus camera
Non-mydriatic Auto Fundus Camera
U.S. OPHTHALMIC, L.L.C.
EFC-2600
In Commercial Distribution

  • 00851158007690 ()


  • Ophthalmic fundus camera
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564052 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564045 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564021 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software
Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system
White Light Module
NEOLIGHT LLC
PCI 40-1005
In Commercial Distribution

  • 00852788008071 ()


  • Ophthalmic fundus camera
ICON Footswitch
NEOLIGHT LLC
PCI 30-1000
In Commercial Distribution

  • 00852788008064 ()


  • Ophthalmic fundus camera
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