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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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i.Terminal 2 Station - 04250668606700

N/A
Carl Zeiss Vision GmbH
000000-2433-519
In Commercial Distribution

  • 04250668606700 ()
000000-2433-519

  • Medical image management system

VISUFIT 1000 Platform - 04250668606663

N/A
Carl Zeiss Vision GmbH
000000-2194-446
In Commercial Distribution

  • 04250668606663 ()
000000-2194-446

  • Medical image management system

Natus - 00382830041751

Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software

Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300) - 08809988780001

No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use

Remidio - 08906096520069

Remidio Connect is web-based application it is intended for displaying, storing images and data from Remidio ophthalmic imaging devices to aid in screening of eye disease.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio Connect
In Commercial Distribution

  • 08906096520069 ()


  • Medical image management system

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

NA - 00841983103537

RNS STRIP RECORDER
NIHON KOHDEN AMERICA, INC.
WS-971R
In Commercial Distribution

  • 00841983103537 ()
WS-971R

  • Centralized patient monitor

NA - 00841983103520

INTERACTIVE REMOTE CNS-6200
NIHON KOHDEN AMERICA, INC.
NK-CE770-CNS-S
In Commercial Distribution

  • 00841983103520 ()
NK-CE770-CNS-S

  • Centralized patient monitor

NA - 00841983103513

INTERACTIVE RMT - DUAL CNS
NIHON KOHDEN AMERICA, INC.
NK-CE770CNS-D
In Commercial Distribution

  • 00841983103513 ()
NK-CE770CNS-D

  • Centralized patient monitor
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