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

  • 00852788008057 ()


  • Ophthalmic fundus camera
Diffuser
NEOLIGHT LLC
PCI 40-1017
In Commercial Distribution

  • 00852788008040 ()


  • Ophthalmic fundus camera
FA Module
NEOLIGHT LLC
PCI 40-1004
In Commercial Distribution

  • 00852788008026 ()


  • Ophthalmic fundus camera
ICON Cart Control Box
NEOLIGHT LLC
PCI 40-1003
In Commercial Distribution

  • 00852788008019 ()


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

  • 00850067214281 ()


  • Ophthalmic fundus camera
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 accessory
Identifeye Health Inc.
815-30020-00
In Commercial Distribution

  • 00850067214236 ()


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

  • 00850067214229 ()


  • Ophthalmic fundus camera
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software
The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software
The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Microswitch
In Commercial Distribution

  • 00862290000319 ()


  • Cognitive assessment software
The Test of Variables of Attention (T.O.V.A.) USB Device is a USB-peripheral that precisely and accurate records and securely stores a subject's responses to the T.O.V.A. test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
USB Device
In Commercial Distribution

  • 00862290000302 ()


  • Cognitive assessment software
Arm blood pressure monitor
1BYONEPRODUCTS INC.
TMB-1585
In Commercial Distribution

  • 00863696000309 ()
  • 00863696000316 ()
  • 10863696000306 ()


  • Telemetric sphygmomanometer
The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Portable
In Commercial Distribution



  • Ophthalmic fundus camera
The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Shuttle
In Commercial Distribution



  • Ophthalmic fundus camera
RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam 3
In Commercial Distribution



  • Ophthalmic fundus camera
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution

  • 00864127000349 ()


  • Cognitive assessment software
No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
1
Not in Commercial Distribution

  • 00864127000325 ()


  • Cognitive assessment software
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
PRESSIO SERIAL TRANSMITTER
SOPHYSA
PSO-TX00
Not in Commercial Distribution

  • 03760124131512 ()


  • Patient monitoring system module, intracranial pressure
PRESSIO ICP INTERFACE CONTROL UNIT
SOPHYSA
PSO-IN00
Not in Commercial Distribution

  • 03760124131499 ()


  • Patient monitoring system module, intracranial pressure
Camera, Ophthalmic, ac-powered
Retina-Ai Health, Inc.
100
In Commercial Distribution

  • B857000 ()


  • Ophthalmic fundus camera
No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera
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
No Description
CLASSYS Inc.
DNC-C1
In Commercial Distribution



  • Ophthalmic fundus camera
No Description
Medical Measurement Systems B.V.
MPP-T
In Commercial Distribution

  • 08717775951087 ()


  • Gastroduodenal motility analysis system
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
FUNDUS CAMERA
CENTERVUE SPA
DRS
In Commercial Distribution

  • 08053677040017 ()


  • Ophthalmic fundus camera
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