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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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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
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