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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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RPM2 Rx - 00850023296351

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
Not in Commercial Distribution

  • 00850023296351 ()
Shoe insole size 4 (men 13.0 to 15.0)

  • Pressure monitoring insole

RPM2 Rx - 00850023296337

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2-3)
Not in Commercial Distribution

  • 00850023296337 ()
Shoe insole size (2-3) (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole

RMP2 Rx - 00850023296306

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
Not in Commercial Distribution

  • 00850023296306 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

STEPRITE - 00850023296061

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
In Commercial Distribution

  • 00850023296061 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole

STEPRITE - 00850023296054

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
In Commercial Distribution

  • 00850023296054 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

STEPRITE - 00850023296047

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (0)
In Commercial Distribution

  • 00850023296047 ()
Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 6.5)

  • Pressure monitoring insole

STEPRITE - 00850023296030

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
In Commercial Distribution

  • 00850023296030 ()
Shoe insole size 00 (women 3.0 to 6.5)

  • Pressure monitoring insole

32" x 24" Adaptive Desk - 00850001752473

Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution

  • 00850001752473 ()


  • Ergonomic workdesk, manual

Adaptive Desk - 00850001752428

Adaptive classroom desk
RIFTON EQUIPMENT
R250
In Commercial Distribution

  • 00850001752428 ()


  • Ergonomic workdesk, manual

Canaview - 00628504370056

Intra Oral Camera, Direct-USB, Auto-Focus
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00628504370056 ()


  • Intraoral camera

KOWA FM-600 - 04987646804024

KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
KOWA COMPANY,LTD.
LSS50BK
In Commercial Distribution

  • 04987646804024 ()

  • Height: 458 Millimeter
  • Depth: 457 Millimeter
  • Width: 274 Millimeter
  • Weight: 18 Kilogram


  • Aqueous flare/cell measuring system

Etymotic Research, Inc. - 00846430004009

Changing tool with filters(orange) HHT
ETYMOTIC RESEARCH, INC.
ER38-46HHT
In Commercial Distribution

  • 00846430004009 ()
  • 00846430004856 ()


  • Tone audiometer

N/A - 00846430004634

Striped Red Tubing 100pk
ETYMOTIC RESEARCH, INC.
ER3-21TR
In Commercial Distribution

  • 00846430004634 ()
  • 00846430004887 ()


  • Tone audiometer

Etymotic Research, Inc. - 00846430004023

Home Hearing Test
ETYMOTIC RESEARCH, INC.
ER120 HHT
In Commercial Distribution

  • 00846430004023 ()


  • Tone audiometer

Etymotic - 00846430004016

Replacement Filters 6pk-orange
ETYMOTIC RESEARCH, INC.
ER38-50HT
In Commercial Distribution

  • 00846430004016 ()
  • 00846430004856 ()


  • Tone audiometer

hearX - 00860003469811

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

  • 00860003469811 ()


  • Tone audiometer

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

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

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

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

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

Orfit Industries - 05420028772577

No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer

ATEC - 05420045503178

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

  • 05420045503178 ()
  • 15420045503175 ()
ATEC RTFA

  • Mammographic stereotactic biopsy system

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

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

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
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