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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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Central Monitoring System - 06944413800229

No Description
Edan Instruments, Inc.
MFM-CMS
In Commercial Distribution

  • 06944413800229 ()


  • Centralized patient monitor

qube mini - 10841522131462

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
In Commercial Distribution

  • 10841522131462 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522131141

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522131141 ()

  • 21.5"
011-0262-00

  • Centralized patient monitor

Xhibit - 10841522129780

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK, ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522129780 ()
011-0241-02

  • Centralized patient monitor

ClinicalAccess® Kiosk - 00085003316723

The ClinicalAccess®, Kiosk is our most secure medical station, designed to be wall mounted or tabletop mounted, it offers all the capabilities you expect from a telemedicine station, in a small form factor. The kiosk comes equipped with 19” touchscreen, 4k conference camera, integrated small form factor PC, and lockable device storage
Globalmed Holdings, LLC
1.0
In Commercial Distribution

  • 00085003316723 ()
1CAK001

  • Medical image management system

X-Guide - 00817421023361

X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022920

X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022838

X-Guide 3.6.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022838 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022821

X-Guide 3.5.8 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022821 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022814

X-Guide 3.5.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022814 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022791

EDX-S Tracker Arm, Vertical, Center
XNAV TECHNOLOGIES LLC
P011803
In Commercial Distribution

  • 00817421022791 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022784

X-Guide 3.5.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022784 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022753

X-Guide 3.5.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022753 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022647

EDX-S Tracker Arm, Horizontal, Right
XNAV TECHNOLOGIES LLC
P010873
In Commercial Distribution

  • 00817421022647 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022630

EDX-S Tracker Arm, Vertical, Right
XNAV TECHNOLOGIES LLC
P010869
In Commercial Distribution

  • 00817421022630 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022623

EDX-S Tracker Arm, Horizontal, Left
XNAV TECHNOLOGIES LLC
P010874
In Commercial Distribution

  • 00817421022623 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022616

EDX-S Tracker Arm, Vertical, Left
XNAV TECHNOLOGIES LLC
P010870
In Commercial Distribution

  • 00817421022616 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022609

X-Guide 3.4.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022609 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022593

X-Guide 3.4.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022593 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022500

WRENCH
XNAV TECHNOLOGIES LLC
P009154
In Commercial Distribution

  • 00817421022500 ()
P009154

  • Surgical planning/navigation-enhancement system
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