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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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EDIS - 04049539069146

No Description
Carl Zeiss Meditec AG
6914
In Commercial Distribution

  • 04049539069146 ()


  • Ophthalmic surgical microscope data overlay unit

Bio30+ System Physio HR - 05056336800260

Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD

Bio30+ System Physio HP - 05056336800222

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD

N/A - 04961333241842

DVD-RW DRIVE, EXTERNAL USB
PENTAX OF AMERICA, INC.
1111-1977
In Commercial Distribution

  • 04961333241842 ()


  • DVD recorder

Kinesis Balance - 05391542950027

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software

Assess Balance - 00860010129111

No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software

FTM-EVAL-AA - 03760349820062

FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software

GN Otometrics A/S - 05713315000331

1072 HI-PRO 2
Natus Medical Denmark ApS
Hearing Instrument Programmer
In Commercial Distribution

  • 05713315000331 ()
8-04-14800

  • Hearing aid/implant system programming interface unit

Interacoustics - 05711117199765

No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software

Avatar Generation - 04250668606670

N/A
Carl Zeiss Vision GmbH
000000-2351-295
Not in Commercial Distribution

  • 04250668606670 ()
000000-2351-295

  • Camera application software
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