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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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No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480
In Commercial Distribution

  • 00851725007221 ()
RNS-6804-7480

  • Centralized patient monitor
No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor
No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor
The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system
Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6011
In Commercial Distribution

  • 00618874601102 ()


  • Electronic epidural space locator pressure-sensing set
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software
Cable to connect MediByte to a computer for configuration and data upload.
Braebon Medical Corporation
8890
In Commercial Distribution

  • B14088900 ()
8890

  • Electrical-only medical device connection cable, reusable
Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD
Corneal topography system
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
DEA520
In Commercial Distribution

  • 06945087500002 ()


  • Corneal topography system
with 31 cone
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612129 ()


  • Corneal topography system
No Description
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution



  • Corneal topography system
100V
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612099 ()


  • Corneal topography system
WAVELIGHT TOPOLYZER VARIO: 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.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system
No Description
MEDMONT INTERNATIONAL PTY LTD
Vantage
In Commercial Distribution

  • 09349221000132 ()


  • Corneal topography system
No Description
MEDMONT INTERNATIONAL PTY LTD
Classic
In Commercial Distribution

  • 09349221000118 ()


  • Corneal topography system
No Description
MEDMONT INTERNATIONAL PTY LTD
Professional
In Commercial Distribution

  • 09349221000101 ()


  • Corneal topography system
No Description
MEDMONT INTERNATIONAL PTY LTD
E300 USB
Not in Commercial Distribution

  • 09349221000033 ()


  • Corneal topography system
The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.20
In Commercial Distribution

  • 04987669100844 ()


  • Corneal topography system
The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.21
In Commercial Distribution

  • 04987669200780 ()


  • Corneal topography system
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
BIOMETER - TOPOGRAPHER
VISIA IMAGING SRL
MYOPIA EXPERT 700
In Commercial Distribution

  • 08034028770517 ()
BMT00004

  • Corneal topography system
No Description
VISIA IMAGING SRL
MYAH
In Commercial Distribution

  • 08034028770487 ()
42-0000983US

  • Corneal topography system
BIOMETER - TOPOGRAPHER
VISIA IMAGING SRL
MYOPIA EXPERT 700
In Commercial Distribution

  • 08034028770463 ()
BMT00004

  • Corneal topography system
No Description
VISIA IMAGING SRL
MYAH
In Commercial Distribution

  • 08034028770456 ()
42-0000983US

  • Corneal topography system
Corneal Topographer HTG-1
Huvitz Co., Ltd.
HTG-1
In Commercial Distribution

  • 08800019600770 ()
HTG-1

  • Corneal topography system
Cassini is a Corneal Topography System. An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface.
Cassini Technologies B.V.
2.0,3.0
In Commercial Distribution

  • 08719326059600 ()


  • Corneal topography system
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