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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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Terumo® Advanced Perfusion System 1 - 00886799000731

The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
Terumo Cardiovascular Systems Corporation
802113
In Commercial Distribution

  • 00886799000731 ()
802113

  • Cardiopulmonary bypass system, roller type

EchoGo - 05060634690065

No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690058

No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690041

No Description
ULTROMICS LIMITED
Heart Failure 1.0
In Commercial Distribution

  • 05060634690041 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690010

No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software

EMG Sensor - 00890477000180

No Description
SRS Medical Systems, Inc.
900-026
In Commercial Distribution

  • 00890477000180 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph

Insight Discovery EMG - 00890477000098

No Description
SRS Medical Systems, Inc.
900-037
In Commercial Distribution

  • 00890477000098 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph

Hepatoscope - 03770023859011

The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system

Barco - 05415334053670

VANTAGEVIEW 2.0 ENCODER HD
Barco NV
MNA-420
In Commercial Distribution

  • 05415334053670 ()
600306027

  • Operating room audiovisual data/device management system

Barco - 05415334053663

VANTAGEVIEW 2.0 DECODER
Barco NV
MNA-240
In Commercial Distribution

  • 05415334053663 ()
600301482

  • Operating room audiovisual data/device management system

Barco - 05415334053472

VANTAGEVIEW 2.0 ANALOG ENCODER
Barco NV
MNA-120
In Commercial Distribution

  • 05415334053472 ()
600301481

  • Operating room audiovisual data/device management system

Barco - 05415334053458

VANTAGEVIEW 2.0 ENCODER 4K
Barco NV
MNA-440
In Commercial Distribution

  • 05415334053458 ()
600301479

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050839

MNA-420 DEC HDMI V2
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050839 ()
K9303331CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050822

MNA-440 DEC HDMI V2
Barco NV
MNA-440
In Commercial Distribution

  • 05415334050822 ()
K9303311CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050815

MNA-420 ENC HDMI
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050815 ()
K9303320CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334042346

NEXXIS WORKSPOT KIT2 CM
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334042346 ()
K9610424

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334039131

NEXXIS SYSTEM X670 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039131 ()
k9605033

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334039124

NEXXIS SYSTEM X620 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039124 ()
k9605034

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037687

MNA-440 ENC SDI IN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334037687 ()
k9303301D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037632

MNA-420 ENC HDMI IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037632 ()
k9303320D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037625

MNA-420 DEC HDMI V2 IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037625 ()
k9303331D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036840

NEXXIS WORKSPOT KIT CM
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036840 ()
K9610421

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036833

NEXXIS SYSTEM X620 CM V5
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036833 ()
K9605032

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036826

NEXXIS SYSTEM X670 CM V5
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036826 ()
K9605031

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036277

NEXXIS ULTIMAX KIT
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334036277 ()
K9610420

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034891

NEXXIS SYSTEM X670 CM V4
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334034891 ()
K9605029

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034877

NEXXIS SYSTEM X620 CM V4
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334034877 ()
K9605030

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034846

MNA-420 DEC HDMI V2 INC SFP+ US
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034846 ()
K9350202B

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034839

MNA-420 DEC HDMI V2 INC SFP+ EU
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034839 ()
K9350202F

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034822

MNA-420 DEC HDMI V2 INC SFP+ UK
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034822 ()
K9350202G

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034815

MNA-420 DEC HDMI V2 INC SFP+ CN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034815 ()
K9350202I

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034303

MNA-420 DEC HDMI V2 INC SFP+ XX
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034303 ()
K9350202X

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034297

MNA-440 DEC HDMI V2 INC SFP+ US
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034297 ()
K9350204B

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034280

MNA-440 DEC HDMI V2 INC SFP+ XX
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034280 ()
K9350204X

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034273

MNA-440 DEC HDMI V2 INC SFP+ CN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034273 ()
K9350204I

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034266

MNA-440 DEC HDMI V2 INC SFP+ UK
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034266 ()
K9350204G

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034259

MNA-440 DEC HDMI V2 INC SFP+ EU
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034259 ()
K9350204F

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033337

NEXXIS SYSTEM X670 CM US V3
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334033337 ()
K9605028

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033047

NEXXIS SYSTEM X620 CM V3
Barco NV
Nexxis
In Commercial Distribution

  • 05415334033047 ()
K9605026

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033030

NEXXIS SYSTEM X670 CM V3
Barco NV
Nexxis
In Commercial Distribution

  • 05415334033030 ()
K9605027

  • Operating room audiovisual data/device management system
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