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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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Myopia Master - 04049584029959

The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
68130
In Commercial Distribution

  • 04049584029959 ()


  • Corneal topography system

Myopia Master - 04049584029942

The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
68120
In Commercial Distribution

  • 04049584029942 ()


  • Corneal topography system

Pentacam AXL Wave - 04049584025357

While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70020
In Commercial Distribution

  • 04049584025357 ()


  • Corneal topography system

Pentacam AXL - 04049584012333

While rotating around the eye, the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70100
In Commercial Distribution

  • 04049584012333 ()

  • Weight: 7.9 Kilogram
  • Height: 430 Millimeter
  • Depth: 208 Millimeter
  • Width: 270 Millimeter


  • Corneal topography system

Keratograph 5M - 04049584000477

The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is reflected off the cornea. These data are analyzed by the computer.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
7700
In Commercial Distribution

  • 04049584000477 ()

  • Weight: 6.1 Kilogram
  • Height: 512 Millimeter
  • Depth: 400 Millimeter
  • Width: 275 Millimeter


  • Corneal topography system

Pentacam HR - 04049584000026

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70900
In Commercial Distribution

  • 04049584000026 ()

  • Height: 535 Millimeter
  • Depth: 360 Millimeter
  • Width: 280 Millimeter
  • Weight: 11 Kilogram


  • Corneal topography system

Pentacam - 04049584000019

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70700
In Commercial Distribution

  • 04049584000019 ()

  • Weight: 10.5 Kilogram
  • Height: 535 Millimeter
  • Depth: 360 Millimeter
  • Width: 280 Millimeter


  • Corneal topography system

ATLAS Corneal Topography System - 04057748081118

The ZEISS ATLAS Corneal Topography System is intended to measure and analyze the corneal curvature of the eye.
Carl Zeiss Meditec, Inc.
9000
Not in Commercial Distribution

  • 04057748081118 ()


  • Corneal topography system

WAVELIGHT REFRACTIVE SUITE - 00380659906060

ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990606
Not in Commercial Distribution

  • 00380659906060 ()

  • Weight: 188 Pound


  • Corneal topography system

BD Intelliport - 00382905167041

KIT TABLET
BECTON, DICKINSON AND COMPANY
516704
In Commercial Distribution

  • 00382905167041 ()
516704

  • Intravenous injection automated detection/documentation system computer

Baha Fitting Software 7 - 09321502075527

VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set

Baha Fitting Software 7 - 09321502075510

No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075510 ()
P2121898

  • Hearing aid wireless-fitting computer-aided set

Baha - 09321502036023

Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
P803254
In Commercial Distribution

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set

Baha - 09321502032834

Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
95430
In Commercial Distribution

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set

Baha - 09321502026383

Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5.2 - 09321502038966

N/A
Cochlear Bone Anchored Solutions AB
P878156
In Commercial Distribution

  • 09321502038966 ()
P878156

  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5.2 - 09321502038959

N/A
Cochlear Bone Anchored Solutions AB
P878155
Not in Commercial Distribution

  • 09321502038959 ()
P878155

  • Hearing aid wireless-fitting computer-aided set

BAHA FITTING SOFTWARE 6 CD - 09321502074124

No Description
Cochlear Americas Corporation
P1682914CD
In Commercial Distribution

  • 09321502074124 ()


  • Hearing aid wireless-fitting computer-aided set

BAHA FITTING SOFTWARE 5 CD - 09321502074117

No Description
Cochlear Americas Corporation
P803255CD
In Commercial Distribution

  • 09321502074117 ()


  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5 - 09321502044097

N/A
Cochlear Bone Anchored Solutions AB
P1457850
In Commercial Distribution

  • 09321502044097 ()
P1457850

  • Hearing aid wireless-fitting computer-aided set

DataLINK Management + Analysis Software (Version 10) - 05060481691949

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-11
In Commercial Distribution

  • 05060481691949 ()


  • Bio-energy mapping system application software

DataLINK Management Software (Version 10) - 05060481691932

The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-00
In Commercial Distribution

  • 05060481691932 ()


  • Bio-energy mapping system application software

DataLITE Management + Analysis Software (Version 10) - 05060481690867

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-11
In Commercial Distribution

  • 05060481690867 ()


  • Bio-energy mapping system application software

DataLITE Management Software (Version 10) - 05060481690850

The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-100
In Commercial Distribution

  • 05060481690850 ()


  • Bio-energy mapping system application software

Bernafon - 05714464159390

AOXT5 FW 1.1.1
Sbo Hearing A/S
280492
In Commercial Distribution

  • 05714464159390 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464159383

AOXT7 FW 1.1.1
Sbo Hearing A/S
280491
In Commercial Distribution

  • 05714464159383 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464159376

AOXT9 FW 1.1.1
Sbo Hearing A/S
280490
In Commercial Distribution

  • 05714464159376 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464150526

V GO T13 FW 1.4.5
Sbo Hearing A/S
277531
In Commercial Distribution

  • 05714464150526 ()


  • Hearing aid wireless-fitting computer-aided set

Soniton - 05714464150519

SONITON Z1.10 FW 1.0.0
Sbo Hearing A/S
277533
In Commercial Distribution

  • 05714464150519 ()


  • Hearing aid wireless-fitting computer-aided set

Soniton - 05714464150502

SONITON Z1.20 FW 1.0.0
Sbo Hearing A/S
277532
In Commercial Distribution

  • 05714464150502 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464150496

PERSONAL 6.4 FW 1.4.5
Sbo Hearing A/S
277529
In Commercial Distribution

  • 05714464150496 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464150489

PERSONAL 5.4 FW 1.4.5
Sbo Hearing A/S
277528
In Commercial Distribution

  • 05714464150489 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464150472

V GO T23 FW 1.4.5
Sbo Hearing A/S
277530
In Commercial Distribution

  • 05714464150472 ()


  • Hearing aid wireless-fitting computer-aided set

Philips - 05714464150250

HEARLINK 1530 FW 1.4.5
Sbo Hearing A/S
277081
In Commercial Distribution

  • 05714464150250 ()


  • Hearing aid wireless-fitting computer-aided set

Philips - 05714464150243

HEARLINK 1730 FW 1.4.5
Sbo Hearing A/S
277080
In Commercial Distribution

  • 05714464150243 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464150236

ENTRA B 10 FW 1.0.0
Sbo Hearing A/S
276162
In Commercial Distribution

  • 05714464150236 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464150229

ENTRA B 20 FW 1.0.0
Sbo Hearing A/S
276161
In Commercial Distribution

  • 05714464150229 ()


  • Hearing aid wireless-fitting computer-aided set

Maico - 05714464150212

Z1.10 FW 1.0.0
Sbo Hearing A/S
277086
In Commercial Distribution

  • 05714464150212 ()


  • Hearing aid wireless-fitting computer-aided set

Maico - 05714464150205

Z1.20 FW 1.0.0
Sbo Hearing A/S
277085
In Commercial Distribution

  • 05714464150205 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464150182

F60 FW 1.4.5
Sbo Hearing A/S
277084
In Commercial Distribution

  • 05714464150182 ()


  • Hearing aid wireless-fitting computer-aided set
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