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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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Synergy ODM 4.05 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
4.05
In Commercial Distribution

  • 00852683007001 ()


  • Camera application software
SPEEDLINK UNIT
Gn Hearing A/S
15874200
In Commercial Distribution

  • 05708296137428 ()


  • Hearing aid/implant system programming interface unit
PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software
Cochlear Nucleus Freedom Programming POD
COCHLEAR LIMITED
Z60686
In Commercial Distribution

  • 09321502009584 ()
Z60686

  • Hearing aid/implant system programming interface unit
CP1000
COCHLEAR LIMITED
Z597944
In Commercial Distribution

  • 09321502038164 ()
Z597944

  • Hearing aid/implant system programming interface unit
N/A
COCHLEAR LIMITED
Z594046
In Commercial Distribution

  • 09321502034401 ()
Z594046

  • Hearing aid/implant system programming interface unit
No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software
No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software
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
The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network. The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
VIVAQUANT, INC.
RX-1
In Commercial Distribution

  • 00860000272414 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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