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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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EV1000 - 00690103193473

PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
PC2K
In Commercial Distribution

  • 00690103193473 ()

  • Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m
PC2K

  • Patient monitoring system module, blood pressure, noninvasive
  • Patient positioning sensor
  • General-purpose multi-parameter bedside monitor

EV1000 - 00690103193374

HEART REFERENCE SENSOR
Edwards Lifesciences LLC
EVHRS
In Commercial Distribution

  • 00690103193374 ()

  • Weight: 36 Gram, Cable Length: 48 Inch
EVHRS

  • Patient positioning sensor

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 Hearing - 05708296051496

SPEEDLINK,COMPL PCK
Gn Hearing A/S
15861300
In Commercial Distribution

  • 05708296051496 ()


  • Hearing aid/implant system programming interface unit

Synergy ODM - 00852683007049

Synergy ODM 4.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.09
In Commercial Distribution

  • 00852683007049 ()


  • Camera application software

Synergy ODM - 00852683007032

Synergy ODM 4.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.08
In Commercial Distribution

  • 00852683007032 ()


  • Camera application software

Synergy ODM - 00852683007025

Synergy ODM 4.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.07
In Commercial Distribution

  • 00852683007025 ()


  • Camera application software

Synergy ODM - 00852683007018

Synergy ODM 4.06 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.06
In Commercial Distribution

  • 00852683007018 ()


  • Camera application software
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