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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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OmniFlow Software - 00858703006313

Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software

Interacoustics - 05711117180565

No Description
Interacoustics A/S
EyeSeeCam
In Commercial Distribution

  • 05711117180565 ()


  • Eye movement analysis system

Interacoustics - 05711117180305

No Description
Interacoustics A/S
PA5
In Commercial Distribution

  • 05711117180305 ()


  • Tone audiometer

Interacoustics - 05711117180244

No Description
Interacoustics A/S
AS608
In Commercial Distribution

  • 05711117180244 ()


  • Tone audiometer

Interacoustics - 05711117180213

No Description
Interacoustics A/S
AD226
In Commercial Distribution

  • 05711117180213 ()


  • Tone audiometer

iCam - 00858475006115

Intraoral Camera
DENTERPRISE INTERNATIONAL, INC.
1000
In Commercial Distribution

  • 00858475006115 ()
01MAG10000

  • Intraoral camera

CONTEC - 06945040106296

Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040106296 ()


  • Blood pressure ambulatory recorder

CONTEC - 06945040100348

Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040100348 ()


  • Blood pressure ambulatory recorder

NeuroMatch - 00850056774000

NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution

  • 00850056774000 ()


  • Bioelectrical signal analysis software

AMBCO - 00851195007011

Audiometer - Model 650AB
AMBCO ELECTRONICS
650AB
In Commercial Distribution

  • 00851195007011 ()
650AB

  • Tone audiometer

AMBCO - 00851195007004

AMBCO Audiometer - Model 650A
AMBCO ELECTRONICS
650A
In Commercial Distribution

  • 00851195007004 ()
650A

  • Tone audiometer

Persyst ESI powered by Epilog - 05430000733045

Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

PreOp - 05430000733021

PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

PreOp - 05430000733007

PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software

ATEC - 05420045503178

REMOTE TISSUE FILTER ADAPTER
Hologic, Inc.
ATEC RTFA
In Commercial Distribution

  • 05420045503178 ()
  • 15420045503175 ()
ATEC RTFA

  • Mammographic stereotactic biopsy system

Orfit Industries - 05420028772577

No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer

Stratus EEG - 05694110068071

The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
In Commercial Distribution



  • Bioelectrical signal analysis software

Stratus EEG - 05694110068064

Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
In Commercial Distribution



  • Bioelectrical signal analysis software

Stratus EEG - 05694110068057

Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
In Commercial Distribution



  • Bioelectrical signal analysis software

Stratus EEG - 05694110068040

Stratus EEG Web is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over the Web without the use of additional remote desktop software solutions. The two main components of Stratus Web are Web Centrum and Web Review.
Kvikna Medical ehf.
Web
In Commercial Distribution

  • 05694110068040 ()


  • Bioelectrical signal analysis software

Lifelines iEEG Server Software - 05694110063069

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2060
Not in Commercial Distribution

  • 05694110063069 ()


  • Bioelectrical signal analysis software

Lifelines iEEG Client Software - 05694110063052

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2050
Not in Commercial Distribution

  • 05694110063052 ()


  • Bioelectrical signal analysis software

Acteon - 10194665007935

Camera, C20 Handpiece, Accessories
A-DEC, INC.
C20
In Commercial Distribution

  • 10194665007935 ()


  • Intraoral camera

A-dec - 10194665007928

KaVo DIAGNO cam Vision Full HD camera Kit
A-DEC, INC.
54.1041.00
In Commercial Distribution

  • 10194665007928 ()
54.1041.00

  • Intraoral camera

Amplivox - 05060488901171

No Description
AMPLIVOX LIMITED
Model 116
In Commercial Distribution

  • 05060488901171 ()


  • Tone audiometer

Amplivox - 05060488901164

No Description
AMPLIVOX LIMITED
Model 170
In Commercial Distribution

  • 05060488901164 ()


  • Tone audiometer

Amplivox - 05060488901102

No Description
AMPLIVOX LIMITED
Model 270
In Commercial Distribution

  • 05060488901102 ()


  • Tone audiometer

Amplivox - 05060488901034

No Description
AMPLIVOX LIMITED
Model 240
In Commercial Distribution

  • 05060488901034 ()


  • Tone audiometer

Amplivox - 05060488901027

No Description
AMPLIVOX LIMITED
Model 260
In Commercial Distribution

  • 05060488901027 ()


  • Tone audiometer

REMI - 00860005388110

REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software

Audhere Software - 00860005068319

No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer

WAHTS - 00860005068302

No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer

hearX - 00860003469811

No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer

Salux™ - 00860007826634

Salux™ Tablet-Controlled Bluetooth Audiometer - The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux Audiometric solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-02
In Commercial Distribution

SALUX-AU-02

  • Tone audiometer

Parallel(TM) - 00860006172008

ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution

  • 00860006172008 ()
01-0001-001

  • Mindfulness/behavioural therapy software, non-clinician-consultative

Swoop Site Quality Assurance Phantom - 00860000606134

The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.
Hyperfine Operations, Inc.
V1.0 (810-11049-01)
In Commercial Distribution

  • 00860000606134 ()


  • MRI phantom, test object

Regulora® - 00860005970209

Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution

  • 00860005970209 ()
60005-97020

  • Mindfulness/behavioural therapy software, non-clinician-consultative

REMI Vigilenz - 00860005388189

REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software

REMI - 00860005388158

REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software

Persyst 15 EEG Review and Analysis Software - 00869732000166

Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution

  • 00869732000166 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000135

The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software

Persyst 14 Review and Analysis Software - 00869732000128

Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution

  • 00869732000128 ()


  • Bioelectrical signal analysis software

Persyst 13 EEG Review and Analysis Software - 00869732000111

Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P13
In Commercial Distribution

  • 00869732000111 ()


  • Bioelectrical signal analysis software

Persyst 12 EEG Review and Analysis Software - 00869732000104

Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P12
In Commercial Distribution

  • 00869732000104 ()


  • Bioelectrical signal analysis software

Meditech - 05999056500068

The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
ABPM-06 (BP6)
In Commercial Distribution

  • 05999056500068 ()


  • Blood pressure ambulatory recorder

Meditech - 05999056500051

The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
ABPM-05 (BP5)
Not in Commercial Distribution

  • 05999056500051 ()
-

  • Blood pressure ambulatory recorder

Meditech - 05999056500044

The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
ABPM-04 (BP4)
Not in Commercial Distribution

  • 05999056500044 ()
-

  • Blood pressure ambulatory recorder

SACCADOMETER - 05906874392027

The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution

  • 05906874392027 ()


  • Eye movement analysis system

SACCADOMETER - 05906874392010

The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution

  • 05906874392010 ()


  • Eye movement analysis system
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