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 OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I
WELCH ALLYN, INC.
901031
Not in Commercial Distribution

  • 00732094199420 ()
39400-NP

  • Tone audiometer, manual
The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system
No Description
GE Healthcare Finland Oy
2069156-001
In Commercial Distribution

  • 00840682116800 ()


  • Image display monitor mount
iOS application portion for Salux™ Tablet-Controlled Audiometer system. 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-SW-02
In Commercial Distribution

SALUX-SW-02

  • Tone audiometer, semi-automated
iOS application portion for Salux™ Tablet-Controlled Audiometer system. 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-SW-01
In Commercial Distribution

  • 00860007826627 ()
SALUX-SW-01

  • Tone audiometer, semi-automated
Headphone portion for 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-HP-01
In Commercial Distribution

  • 00860007826610 ()
SALUX-HP-01

  • Tone audiometer, semi-automated
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
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 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
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