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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 - 00841983102189

VL cable set (Second), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P8
In Commercial Distribution

  • 00841983102189 ()
YS-097P8

  • Centralized patient monitor

NA - 00841983102172

VL cable set (Main), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P6
In Commercial Distribution

  • 00841983102172 ()
YS-097P6

  • Centralized patient monitor

NA - 00841983102165

VL cable set (Main), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P5
In Commercial Distribution

  • 00841983102165 ()
YS-097P5

  • Centralized patient monitor

NA - 00841983101700

Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-612P
In Commercial Distribution

  • 00841983101700 ()
YL-612P

  • Centralized patient monitor

NA - 00841983101694

Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-611P
In Commercial Distribution

  • 00841983101694 ()
YL-611P

  • Centralized patient monitor

NA - 00841983101410

POWER SUPPLY KIT FOR WS-960P
NIHON KOHDEN AMERICA, INC.
SC-611R
In Commercial Distribution

  • 00841983101410 ()
SC-611RA

  • Centralized patient monitor

NA - 00841983101083

Central Monitoring Station
NIHON KOHDEN AMERICA, INC.
PU-621R
In Commercial Distribution

  • 00841983101083 ()
PU-621RA

  • 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

Viewer - 04056481143800

No Description
Brainlab AG
5.3
In Commercial Distribution

  • 04056481143800 ()


  • Medical image management system

Elements Viewer - 04056481143619

No Description
Brainlab AG
5.2
In Commercial Distribution

  • 04056481143619 ()


  • Medical image management system

Buzz 2.0 - 04056481143305

No Description
Brainlab AG
15800A
In Commercial Distribution

  • 04056481143305 ()


  • Medical image management system

Buzz Virtual - 04056481143046

No Description
Brainlab AG
15501
In Commercial Distribution

  • 04056481143046 ()


  • Medical image management system

Buzz Compact - 04056481143039

No Description
Brainlab AG
15790
In Commercial Distribution

  • 04056481143039 ()


  • Medical image management system

Viewer - 04056481142513

No Description
Brainlab AG
5.1
In Commercial Distribution

  • 04056481142513 ()


  • Medical image management system

Vscan - 00195278884749

Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software

Vscan - 00195278884725

Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software

Venue Sprint - 00195278754011

Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software

Digital Expert Access - 00195278707741

DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
GE HEALTHCARE
with Remote scanning for MR
In Commercial Distribution

  • 00195278707741 ()
5941611

  • MRI system application software

Universal Viewer - 00195278644039

MD UV 8.1 MEDICAL DEVICE
GE HEALTHCARE
8.1
In Commercial Distribution

  • 00195278644039 ()


  • Medical image management system

Vscan - 00195278640574

Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software

Vscan - 00195278640567

Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software

Vscan - 00195278640550

Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software

Portrait VSM - 00195278561312

Portrait VSM ATO MODEL
Ge Medical Systems Information Technologies, Inc.
MVC101
In Commercial Distribution

  • 00195278561312 ()
6660000-666

  • Multiple vital physiological parameter monitoring system, clinical

Universal Viewer - 00195278379610

MD UV 8 MEDICAL DEVICE
GE HEALTHCARE
8
In Commercial Distribution

  • 00195278379610 ()


  • Medical image management system

CARESCAPE ONE - 00195278288639

CARESCAPE ONE MBZ323 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ323
In Commercial Distribution

  • 00195278288639 ()
2087075-300

  • Multiple vital physiological parameter monitoring system, clinical

DaTQUANT - 00195278011343

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
2.0
In Commercial Distribution

  • 00195278011343 ()


  • SPECT system application software

Upgrade Kit XA60A - 04056869984681

No Description
Siemens Healthcare GmbH
11689973
In Commercial Distribution

  • 04056869984681 ()


  • MRI system application software

Chondral Quant - 04056869964386

No Description
Siemens Healthcare GmbH
VA10A
In Commercial Distribution

  • 04056869964386 ()


  • MRI system application software

syngo.MR Applications - 04056869230214

No Description
Siemens Healthcare GmbH
11410391
In Commercial Distribution

  • 04056869230214 ()


  • MRI system application software

syngo.MR Applications - 04056869163185

No Description
Siemens Healthcare GmbH
11344736
In Commercial Distribution

  • 04056869163185 ()


  • MRI system application software

Wrist Array Coil C035(4 ch) Kit - 04056869049717

Contains Medical Device Mat. 10045324 (GTIN:04056869038902)
Siemens Shenzhen Magnetic Resonance Ltd.
10045327
In Commercial Distribution

  • 04056869049717 ()


  • Full-body MRI system, permanent magnet

BODY SPINE LOWER MR COIL PART - 04056869049700

Contains Medical Device Mat. 10352808 (GTIN:04056869049854)
Siemens Shenzhen Magnetic Resonance Ltd.
10019428
In Commercial Distribution

  • 04056869049700 ()


  • Full-body MRI system, permanent magnet

Shoulder coil kit c035 - 04056869049694

Contains Medical Device Mat. 8635620 (GTIN:04056869038865)
Siemens Shenzhen Magnetic Resonance Ltd.
10019365
In Commercial Distribution

  • 04056869049694 ()


  • Full-body MRI system, permanent magnet

Body spine array XL kit - 04056869049687

Contains Medical Device Mat. 8635513 (GTIN:04056869038889)
Siemens Shenzhen Magnetic Resonance Ltd.
10019290
In Commercial Distribution

  • 04056869049687 ()


  • Full-body MRI system, permanent magnet
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