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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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Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667NEXY01 ()
  • B667NEXY1 ()


  • Ophthalmic fundus camera
No Description
Linus Health, Inc.
20005
In Commercial Distribution

  • B626200050 ()
20005

  • Cognitive assessment software
No Description
Linus Health, Inc.
20002
Not in Commercial Distribution

  • B626200020 ()


  • Cognitive assessment software
Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software
Penfield 1 Cup/Dissector
Buxton Biomedical Inc
72-1101
In Commercial Distribution

  • B7687211010 ()
72-1101

  • Telemetric sphygmomanometer
Camera, Ophthalmic, ac-powered
Retina-Ai Health, Inc.
100
In Commercial Distribution

  • B857000 ()


  • Ophthalmic fundus camera
HANDLE & CHARGER F/HORUS SERIES 3P
JEDMED INSTRUMENT COMPANY
39-7420-3P
In Commercial Distribution

  • M6333974203P0 ()
39-7420-3P

  • Ophthalmic fundus camera
HANDLE F/FUNDUS HORUS SERIES 3
JEDMED INSTRUMENT COMPANY
39-7420-3
In Commercial Distribution

  • M63339742030 ()
39-7420-3

  • Ophthalmic fundus camera
HANDLE & CHARGER F/HORUS SERIES 2P
JEDMED INSTRUMENT COMPANY
39-7420-2P
In Commercial Distribution

  • M6333974202P0 ()
39-7420-2P

  • Ophthalmic fundus camera
HANDLE & CHARGER F/HORUS SERIES 2
JEDMED INSTRUMENT COMPANY
39-7420-2
In Commercial Distribution

  • M63339742020 ()
39-7420-2

  • Ophthalmic fundus camera
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