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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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FUKUDA DENSHI - 04538612915826

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800L
In Commercial Distribution

  • 04538612915826 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612912061

No Description
FUKUDA DENSHI CO.,LTD.
LC-8026T
In Commercial Distribution

  • 04538612912061 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612912047

No Description
FUKUDA DENSHI CO.,LTD.
DS-8900
In Commercial Distribution

  • 04538612912047 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915895

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812R
In Commercial Distribution

  • 04538612915895 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915888

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800LR
In Commercial Distribution

  • 04538612915888 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915840

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812
In Commercial Distribution

  • 04538612915840 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612911071

No Description
FUKUDA DENSHI CO.,LTD.
LW-7080(G)
In Commercial Distribution

  • 04538612911071 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908354

No Description
FUKUDA DENSHI CO.,LTD.
DS-7780W
In Commercial Distribution

  • 04538612908354 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908330

No Description
FUKUDA DENSHI CO.,LTD.
DS-7700WL
In Commercial Distribution

  • 04538612908330 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908316

No Description
FUKUDA DENSHI CO.,LTD.
DS-7780
In Commercial Distribution

  • 04538612908316 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908293

No Description
FUKUDA DENSHI CO.,LTD.
DS-7700L
In Commercial Distribution

  • 04538612908293 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908279

No Description
FUKUDA DENSHI CO.,LTD.
LW-7080
In Commercial Distribution

  • 04538612908279 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908248

No Description
FUKUDA DENSHI CO.,LTD.
LC-7019FT
In Commercial Distribution

  • 04538612908248 ()


  • Centralized patient monitor

Kosmos OTS iOS - 09353278000823

Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software

Kosmos OTS iOS - 09353278000762

KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software

Kosmos OTS iOS Software Package - 09353278000717

Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Doppler Software Package - 09353278000700

Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Linear Color - 09353278000694

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Linear - 09353278000687

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software

Kosmos OTS - 09353278000588

Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software

Criticare - D438506DNBUS0

Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

PlaDuo System - 08800017100159

No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017100159 ()


  • Nitrogen plasma skin surface treatment system

XHIBIT - 10841522117688

CENTRAL STATION,96102,REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
Xhibit Central
In Commercial Distribution

  • 10841522117688 ()
R-96102

  • Centralized patient monitor

Spacelabs Healthcare - 10841522113116

ELANCE VITAL SIGNS MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522113116 ()
93300

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522108723

ADVANCED COMPACT MONITOR, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91370
Not in Commercial Distribution

  • 10841522108723 ()
R-91370

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522107832

CENTRAL STATION,96102,LOANER
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522107832 ()
L-96102

  • Centralized patient monitor

UltraviewSL - 10841522107757

91369 MONITOR, COMPACT
SPACELABS HEALTHCARE (WASHINGTON), INC
91369
Not in Commercial Distribution

  • 10841522107757 ()
L-91369

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522107160

Central Station
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522107160 ()
N/A

  • Centralized patient monitor

Spacelabs Healthcare - 10841522104985

KIT,START-UP,3-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104985 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104954

KIT,START-UP,5-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104954 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104947

KIT,START UP KIT UPGRADE,SKIN TEMP SENSOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104947 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104930

KIT,START UP KIT UPGRADE,5-L ECG AAMI
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104930 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102974

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100574

COMPACT MONITOR, 91390, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube
In Commercial Distribution

  • 10841522100574 ()
R-91390

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100550

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
91390
Not in Commercial Distribution

  • 10841522100550 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522100536

DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522100536 ()
011-0241-01

  • Centralized patient monitor

Xhibit - 10841522100345

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522100345 ()
96102

  • Centralized patient monitor

qube mini - 10841522100239

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
Not in Commercial Distribution

  • 10841522100239 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522100222

Remote Display Controller
SPACELABS HEALTHCARE (WASHINGTON), INC
91388
In Commercial Distribution

  • 10841522100222 ()
N/A

  • 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
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