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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, Inc. - 00732094258851

RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094258851 ()
RV700-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094252835

RETINAVUE100 IMAGER PRO SET US PLUG
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094252835 ()
RV100PRO-B

  • Ophthalmic fundus camera

ATOMLAB - 00718175000137

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

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000021

Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000014

Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system

Optain - 00860014304507

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

EntireEye Portable - 00860011978305

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

  • 00860011978305 ()


  • Ophthalmic fundus camera

SPARK Neuro - 00860011882022

No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software

Cognition Snapshot+ v2.4 - 00860011850922

No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software

MSPT Web v3.1.0 - 00860011850915

No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software

MSPT v3.1.1 - 00860011850908

No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution

  • 00860011850908 ()


  • Cognitive assessment software

BrainCheck Assess - 00860011154501

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

  • 00860011154501 ()


  • Cognitive assessment software

DANA™ - 00860011042105

No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution

  • 00860011042105 ()


  • Cognitive assessment software

Oivi Opthalmic Fundus Camera - 00860010826812

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

Cognitive Assessment Battery (CAB)® PRO - 00860009958104

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

Speech Vitals - Cognition - 00860009693401

No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution

  • 00860009693401 ()


  • Cognitive assessment software

Neurotrack Cognitive Assessment Battery - 00860009484504

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

Spect Ophthalmic Camera - 00853501008002

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

Phoenix ICON GO - 00857253006088

The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye.
Phoenix Clinical
PCI 40-2001
In Commercial Distribution

  • 00857253006088 ()


  • Ophthalmic fundus camera

Phoenix Clinical White Light Module - 00857253006064

White light module for the Phoenix Clinical ICON retinal imaging system.
Phoenix Clinical
PCI 40-1005
In Commercial Distribution

  • 00857253006064 ()
  • 00857253006095 ()
  • 00857253006125 ()
PCI 40-1005

  • Ophthalmic fundus camera

Phoenix ICON Cart System - 00857253006057

The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
Phoenix Clinical
PCI 40-1000
In Commercial Distribution

  • 00857253006057 ()


  • Ophthalmic fundus camera

Phoenix Clinical ICON - 00857253006040

The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information.
Phoenix Clinical
PJZ
In Commercial Distribution

  • 00857253006040 ()
PCI-40-1000-P

  • Ophthalmic fundus camera

Phoenix Clinical ICON Control Box - 00857253006026

Phoenix Clinical ICON Control Box
Phoenix Clinical
PCI 40-1003
In Commercial Distribution

  • 00857253006026 ()
PCI 40-1003

  • Ophthalmic fundus camera

Phoenix Clinical ICON Cart - 00857253006002

Phoenix Clinical ICON cart assembly.
Phoenix Clinical
PCI 40-1001
In Commercial Distribution

  • 00857253006002 ()
PCI 40-1001

  • Ophthalmic fundus camera

iCam - 00858848006780

iCam 12 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006780 ()
700-54524-001

  • Ophthalmic fundus camera

Vivicon - 00858848006445

Ophthalmic Camera
OPTOVUE, INC.
Vivicon
In Commercial Distribution

  • 00858848006445 ()
700-53597-001

  • Ophthalmic fundus camera

iCam - 00858848006414

iCam Camera Head 5MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006414 ()
700-49517-004

  • Ophthalmic fundus camera

iCam - 00858848006339

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006339 ()
700-49517-003

  • Ophthalmic fundus camera

iCam - 00858848006322

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006322 ()
700-49517-002

  • Ophthalmic fundus camera

iCam - 00858848006278

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006278 ()
700-49517-001

  • Ophthalmic fundus camera

1 BY ONE - 00858069007184

No Description
1BYONEPRODUCTS INC.
9-JK14US05
In Commercial Distribution

  • 00858069007191 ()
  • 00858069007184 ()
  • 10858069007198 ()


  • Telemetric sphygmomanometer

1 BY ONE - 00858069007153

No Description
1BYONEPRODUCTS INC.
9-JK14US06
In Commercial Distribution

  • 00858069007177 ()
  • 00858069007153 ()
  • 10858069007174 ()


  • Telemetric sphygmomanometer

1BYONE - 00858069007030

Wireless Arm Blood Pressure Monitor
1BYONEPRODUCTS INC.
TMB-1585-BT
In Commercial Distribution

  • 10858069007044 ()
  • 00858069007047 ()
  • 00858069007030 ()


  • Telemetric sphygmomanometer

MediWorks - 06945087516010

The device is used to observe, capture and record retina images through examining pupil.
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC160
In Commercial Distribution

  • 06945087516010 ()


  • Ophthalmic fundus camera

Mediworks - 06945087516225

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC162
In Commercial Distribution

  • 06945087516225 ()


  • Ophthalmic fundus camera

Mediworks - 06945087516102

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC161
In Commercial Distribution

  • 06945087516102 ()


  • Ophthalmic fundus camera

Mediworks - 06945087500088

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC163
In Commercial Distribution

  • 06945087500088 ()


  • Ophthalmic fundus camera

CCO/SvO2 module accessories - 06944904086224

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-004083-00
In Commercial Distribution

  • 06944904086224 ()


  • Patient monitoring system module, intracranial pressure

ScvO2 function upgrade kit - 06944904086187

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-007590-00
In Commercial Distribution

  • 06944904086187 ()


  • Patient monitoring system module, intracranial pressure

SCVO2 Module(Package/no accessory) - 06944904085814

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013199-00
In Commercial Distribution

  • 06944904085814 ()


  • Patient monitoring system module, intracranial pressure

CCO/SvO2 Module(Package/no accessory) - 06944904085791

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013196-00
In Commercial Distribution

  • 06944904085791 ()


  • Patient monitoring system module, intracranial pressure

identifeye Camera System, reconditioned - 00850067214281

The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera

identifeye Camera System - 00850067214274

The identifeye Camera System is a fundus ophthalmic camera.
Identifeye Health Inc.
850-30003-00
In Commercial Distribution

  • 00850067214274 ()


  • Ophthalmic fundus camera

identifeye Camera System, power supply - 00850067214236

identifeye Camera System power supply accessory
Identifeye Health Inc.
815-30020-00
In Commercial Distribution

  • 00850067214236 ()


  • Ophthalmic fundus camera

identifeye Camera System, tablet - 00850067214229

identifeye Camera System tablet accessory
Identifeye Health Inc.
815-30023-01
In Commercial Distribution

  • 00850067214229 ()


  • Ophthalmic fundus camera

Neolight - 00852788008071

White Light Module
NEOLIGHT LLC
PCI 40-1005
In Commercial Distribution

  • 00852788008071 ()


  • Ophthalmic fundus camera

Neolight - 00852788008064

ICON Footswitch
NEOLIGHT LLC
PCI 30-1000
In Commercial Distribution

  • 00852788008064 ()


  • Ophthalmic fundus camera

Neolight - 00852788008057

ICON GO Control Box
NEOLIGHT LLC
PCI 40-1030
In Commercial Distribution

  • 00852788008057 ()


  • Ophthalmic fundus camera

Neolight - 00852788008040

Diffuser
NEOLIGHT LLC
PCI 40-1017
In Commercial Distribution

  • 00852788008040 ()


  • Ophthalmic fundus camera

Neolight - 00852788008026

FA Module
NEOLIGHT LLC
PCI 40-1004
In Commercial Distribution

  • 00852788008026 ()


  • Ophthalmic fundus camera
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