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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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neotivCare - 04262390860015

The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution

  • 04262390860015 ()


  • Cognitive assessment software

SOPHYSA - 03760124131512

PRESSIO SERIAL TRANSMITTER
SOPHYSA
PSO-TX00
Not in Commercial Distribution

  • 03760124131512 ()


  • Patient monitoring system module, intracranial pressure

SOPHYSA - 03760124131499

PRESSIO ICP INTERFACE CONTROL UNIT
SOPHYSA
PSO-IN00
Not in Commercial Distribution

  • 03760124131499 ()


  • Patient monitoring system module, intracranial pressure

CADENCE - B857000

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

  • B857000 ()


  • Ophthalmic fundus camera

RetiCapture - 08800023201017

No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera

Fundus Camera HFC-1 - 08800019600541

HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye 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.
Huvitz Co., Ltd.
HFC-1
In Commercial Distribution

  • 08800019600541 ()
HFC-1

  • Ophthalmic fundus camera

Reticapture - 08800016904055

No Description
CLASSYS Inc.
DNC-C1
In Commercial Distribution



  • Ophthalmic fundus camera

MPP-T - 08717775951087

No Description
Medical Measurement Systems B.V.
MPP-T
In Commercial Distribution

  • 08717775951087 ()


  • Gastroduodenal motility analysis system

DRSplus - 08053677040116

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.
CENTERVUE SPA
DRSplus
In Commercial Distribution

  • 08053677040116 ()


  • Ophthalmic fundus camera

DRS - 08053677040017

FUNDUS CAMERA
CENTERVUE SPA
DRS
In Commercial Distribution

  • 08053677040017 ()


  • Ophthalmic fundus camera
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