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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Bluetooth audiometer portion of Salux™ Tablet-Controlled 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™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-01
In Commercial Distribution

  • 00860007826603 ()
SALUX-AU-01

  • Tone audiometer, semi-automated
The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK.
NORAV MEDICAL LTD.
ECGUSB1D-EX-FW11/B
In Commercial Distribution

  • 07290110251062 ()
  • 07290110250010 ()
ECG Module

  • Electrocardiography telemetric monitoring system
No Description
GE Healthcare Finland Oy
2069156-001
In Commercial Distribution

  • 00840682116800 ()


  • Image display monitor mount
The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
LE230
In Commercial Distribution

  • 05060481690638 ()


  • Electromyography telemetric monitoring system transmitter
The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam. Utilized with software only device accessory Varia-NCI.
NEUROCHAOS SOLUTIONS INC
1
In Commercial Distribution

  • B41278000 ()
7800

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
D.E.HOKANSON, INC.
MD35
In Commercial Distribution

  • 00817065022577 ()
00498

  • Limb plethysmograph
  • Paper chart recorder
  • Noninvasive vascular ultrasound system, line-powered
DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
D.E.HOKANSON, INC.
MD35
Not in Commercial Distribution

  • 00817065021389 ()
00496

  • Noninvasive vascular ultrasound system, line-powered
  • Paper chart recorder
  • Limb plethysmograph
DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
D.E.HOKANSON, INC.
MD35
In Commercial Distribution

  • 00817065022447 ()
00497

  • Limb plethysmograph
  • Paper chart recorder
  • Noninvasive vascular ultrasound system, line-powered
The Radlink Laser Pro 16 is a film digitization system that follows a three-step process of acquiring, selecting, and sending digitized films to any desired destination. A laser beam light source and a sealed optic path are used to scan the film that is driven by a clocked, stepping motor. It utilizes a 12-film auto loader, and its software provides image quality control and post-processing functions and enables distribution and routing of DICOM images through a healthcare network.
RADLINK, INC.
LP100
In Commercial Distribution

  • 00866389000167 ()


  • Radiography digital imaging scanner
The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required. Length – approximately 36” / Weight – approximately 5 oz.
ORTHO KINEMATICS, INC.
3.0
In Commercial Distribution

  • 00868579000278 ()


  • Radiographic image marker, manual
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