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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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NA - 04931921107799

Alarm indicator, cable length
NIHON KOHDEN CORPORATION
YL-611P
In Commercial Distribution

  • 04931921107799 ()
YL-611P

  • Centralized patient monitor

CNS-2101 Central Monitor - 04931921017166

Central Monitor
NIHON KOHDEN CORPORATION
CNS-2101
Not in Commercial Distribution

  • 04931921017166 ()
CNS-2101

  • Centralized patient monitor

CNS-2101 Central Monitor - 04931921017159

Central Monitor
NIHON KOHDEN CORPORATION
CNS-2101
In Commercial Distribution

  • 04931921017159 ()
CNS-2101

  • Centralized patient monitor

NA - 04931921000663

Central Monitor Main Unit
NIHON KOHDEN CORPORATION
MU-971RA
In Commercial Distribution

  • 04931921000663 ()


  • Centralized patient monitor

NA - 04931921000656

VL cable set, (second)
NIHON KOHDEN CORPORATION
YS-113P9
In Commercial Distribution

  • 04931921000656 ()
YS-113P9

  • Centralized patient monitor

NA - 04931921000649

VL cable set, (second)
NIHON KOHDEN CORPORATION
YS-113P8
In Commercial Distribution

  • 04931921000649 ()
YS-113P8

  • Centralized patient monitor

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

APERTO Lucent - 04573596200704

Magnetic Resonance Diagnostic Device
FUJIFILM CORPORATION
APERTO Lucent
In Commercial Distribution

  • 04573596200704 ()
APERTO Lucent

  • Full-body MRI system, permanent magnet

SNAP Patient Engagement - 00863157000374

Surgical Navigation Advanced Platform (SNAP) Patient Engagement Mobile System
SURGICAL THEATER LLC
PE SNAP
In Commercial Distribution

  • 00863157000374 ()


  • Surgical planning/navigation-enhancement system

SNAP Mini Desktop - 00863157000367

Surgical Navigation Advanced Platform (SNAP) Patient Engagement Desktop System
SURGICAL THEATER LLC
VR MSNAP
In Commercial Distribution

  • 00863157000367 ()


  • Surgical planning/navigation-enhancement system

All-in-One Clinic Viewer - 00863157000350

SuRgical Planner (SRP) Clinic Viewer Desktop
SURGICAL THEATER LLC
All-in-One
In Commercial Distribution

  • 00863157000350 ()


  • Surgical simulation system

Notebook Clinic Viewer - 00863157000343

SuRgical Planner (SRP) Clinic Viewer Notebook
SURGICAL THEATER LLC
Notebook
In Commercial Distribution

  • 00863157000343 ()


  • Surgical simulation system

SRP - 00863157000336

SuRgical Planner (SRP) Desktop System
SURGICAL THEATER LLC
SRP
In Commercial Distribution

  • 00863157000336 ()


  • Surgical simulation system

Endo SNAP - 00863157000329

Endoscope Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
Endo SNAP
In Commercial Distribution

  • 00863157000329 ()


  • Surgical planning/navigation-enhancement system

SNAP Desktop - 00863157000312

Surgical Navigation Advanced Platform (SNAP) Desktop System
SURGICAL THEATER LLC
VR SNAP
In Commercial Distribution

  • 00863157000312 ()


  • Surgical planning/navigation-enhancement system

SNAP OR - 00863157000305

Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SNAP
In Commercial Distribution

  • 00863157000305 ()


  • Surgical planning/navigation-enhancement system

VIDCO NewtViewer - VIDCO Protocol - 00863067000334

Remote Central Station - Vidco Protocol
VIDCO, INC
MDP2040-0200
In Commercial Distribution

  • 00863067000334 ()


  • Centralized patient monitor

VIDCO MDP - 00863067000327

Remote Viewer and Charting Station for Labor and Delivery Central Station.
VIDCO, INC
MDP2040-0600RV
In Commercial Distribution

  • 00863067000327 ()


  • Centralized patient monitor

VIDCO MDP - 00863067000310

Labor and Delivery Central Station
VIDCO, INC
MDP2020-0600
In Commercial Distribution

  • 00863067000310 ()


  • Centralized patient monitor

VIDCO NetViewer - 00863067000303

Remote Central Station
VIDCO, INC
MDP2040-0100
In Commercial Distribution

  • 00863067000303 ()


  • Centralized patient monitor
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