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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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IMAGE DIAGNOSTICS INC - 00850977007454

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,ILEX32,#A280-0630 OR #A280-0821 FOR THE 4K VERSION
IMAGE DIAGNOSTICS, INC.
ilex32
In Commercial Distribution

  • 00850977007454 ()
A280-0630 & A280-0821

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007447

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,230V,#A280-0781
IMAGE DIAGNOSTICS, INC.
ilex55, 230V
In Commercial Distribution

  • 00850977007447 ()
A280-0781

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007430

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
IMAGE DIAGNOSTICS, INC.
ilex55, 120V
In Commercial Distribution

  • 00850977007430 ()
A280-0600 OR A280-0700

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871282

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS WITH RECORDER,ILEX DUO,120V,#A280-1569
IMAGE DIAGNOSTICS, INC.
ILEX DUO PLATINUM 32
In Commercial Distribution

  • 00850061871282 ()
A280-1569

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871275

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS,ILEX DUO,120V,#A280-1568
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT PREMIUM 32
In Commercial Distribution

  • 00850061871275 ()
A280-1568

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871268

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,ILEX DUO,120V,#A280-1567
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT CONNECT 27
In Commercial Distribution

  • 00850061871268 ()
A280-1567

  • Diagnostic x-ray digital imaging system workstation

ESSENZ - 04033817903178

No Description
LivaNova Deutschland GmbH
Perfusion System Monitor
In Commercial Distribution

  • 04033817903178 ()


  • Patient health record information system

ESSENZ - 04033817903161

No Description
LivaNova Deutschland GmbH
Patient Monitor Software
In Commercial Distribution

  • 04033817903161 ()


  • Patient health record information system

Yumizen P8000 - 03610230008966

1 connexion
HORIBA ABX SAS
1300033327
In Commercial Distribution

  • 03610230008966 ()


  • Clinical laboratory information system

C015 - 08053470960017

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XL C015
In Commercial Distribution

  • 08053470960017 ()


  • Diagnostic x-ray digital imaging system workstation

C015 - 08053470960000

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XS C015
In Commercial Distribution

  • 08053470960000 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali - 08057737122361

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343-TS
In Commercial Distribution

  • 08057737122361 ()


  • Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali - 08057737122262

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343 FL
In Commercial Distribution

  • 08057737122262 ()


  • Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali - 08057737122217

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343
In Commercial Distribution

  • 08057737122217 ()


  • Diagnostic x-ray digital imaging system workstation

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377058539

PULSE LessRay Tablet, Labeled
Nuvasive, Inc.
1833071
In Commercial Distribution

  • 00195377058539 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377058508

PULSE LessRay Battery Pk, Tablet Labeled
Nuvasive, Inc.
1802417
In Commercial Distribution

  • 00195377058508 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057037

PULSE LessRay Tablet Charging Station
Nuvasive, Inc.
1801815
In Commercial Distribution

  • 00195377057037 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057020

PULSE LessRay GE C-arm Mount
Nuvasive, Inc.
1801814
In Commercial Distribution

  • 00195377057020 ()


  • Diagnostic x-ray digital imaging system workstation

Mural Clinical Viewer - 00195278990945

MD Mural Clinical Viewer 1.3 MEDICAL DEVICE
Ge Medical Systems Information Technologies, Inc.
1.3
In Commercial Distribution

  • 00195278990945 ()


  • Patient health record information system

Mural Clinical Viewer - 00195278789846

MD Mural Clinical Viewer 1.2 MEDICAL DEVICE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
1.2
In Commercial Distribution

  • 00195278789846 ()


  • Patient health record information system

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

Senolris - 00840682104395

SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation

CENTRICITY - 00840682102681

MD CPN 6.96 MEDICAL DEVICE
GE HEALTHCARE
PERINATAL6.96
Not in Commercial Distribution

  • 00840682102681 ()


  • Patient health record information system

Home Monitoring Service Center - 04035479167493

No Description
BIOTRONIK SE & Co. KG
3.46
Not in Commercial Distribution

  • 04035479167493 ()
451624

  • Patient health record information system

Home Monitoring Service Center - 04035479166403

No Description
BIOTRONIK SE & Co. KG
3.45
Not in Commercial Distribution

  • 04035479166403 ()
448494

  • Patient health record information system

Graffiti - 00840682152754

MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
GE HEALTHCARE
NotifyMe V1.0
Not in Commercial Distribution

  • 00840682152754 ()


  • Patient health record information system

SenoIris - 00840682147767

SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation

NA - 00840682146555

Half Workstation PC Assembly
GE Hualun Medical Systems Co., Ltd
5835165
In Commercial Distribution

  • 00840682146555 ()


  • Diagnostic x-ray digital imaging system workstation

Centricity - 00840682141642

MD CPN 6.98 MEDICAL DEVICE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Perinatal 6.98
In Commercial Distribution

  • 00840682141642 ()


  • Patient health record information system

Home Monitoring Service Center - 04035479166106

No Description
BIOTRONIK SE & Co. KG
3.44
Not in Commercial Distribution

  • 04035479166106 ()
448495

  • Patient health record information system

Home Monitoring Service Center - 04035479161750

No Description
BIOTRONIK SE & Co. KG
3.43
Not in Commercial Distribution

  • 04035479161750 ()
442662

  • Patient health record information system

Home Monitoring Service Center - 04035479152437

No Description
BIOTRONIK SE & Co. KG
3.37
In Commercial Distribution

  • 04035479152437 ()
419324

  • Patient health record information system

Home Monitoring Service Center - 04035479152420

No Description
BIOTRONIK SE & Co. KG
3.36
In Commercial Distribution

  • 04035479152420 ()
419323

  • Patient health record information system

Home Monitoring Service Center - 04035479152413

No Description
BIOTRONIK SE & Co. KG
3.35
Not in Commercial Distribution

  • 04035479152413 ()
419322

  • Patient health record information system

Home Monitoring Service Center - 04035479152406

No Description
BIOTRONIK SE & Co. KG
3.34
In Commercial Distribution

  • 04035479152406 ()
419321

  • Patient health record information system

Home Monitoring Service Center - 04035479148867

No Description
BIOTRONIK SE & Co. KG
3.33
Not in Commercial Distribution

  • 04035479148867 ()
408411

  • Patient health record information system

Home Monitoring Service Center - 04035479148850

No Description
BIOTRONIK SE & Co. KG
3.32
In Commercial Distribution

  • 04035479148850 ()
408410

  • Patient health record information system

Home Monitoring Service Center - 04035479148843

No Description
BIOTRONIK SE & Co. KG
3.31
Not in Commercial Distribution

  • 04035479148843 ()
408409

  • Patient health record information system

Home Monitoring Service Center - 04035479148836

No Description
BIOTRONIK SE & Co. KG
3.30
In Commercial Distribution

  • 04035479148836 ()
408408

  • Patient health record information system

Home Monitoring Service Center - 04035479161743

No Description
BIOTRONIK SE & Co. KG
3.42
Not in Commercial Distribution

  • 04035479161743 ()
442661

  • Patient health record information system

Home Monitoring Service Center - 04035479158958

No Description
BIOTRONIK SE & Co. KG
3.41
In Commercial Distribution

  • 04035479158958 ()
437704

  • Patient health record information system

Home Monitoring Service Center - 04035479158941

No Description
BIOTRONIK SE & Co. KG
3.40
In Commercial Distribution

  • 04035479158941 ()
437703

  • Patient health record information system

Home Monitoring Service Center - 04035479158354

No Description
BIOTRONIK SE & Co. KG
3.39
In Commercial Distribution

  • 04035479158354 ()
435437

  • Patient health record information system

Home Monitoring Service Center - 04035479158248

No Description
BIOTRONIK SE & Co. KG
3.38
Not in Commercial Distribution

  • 04035479158248 ()
434353

  • Patient health record information system

Home Monitoring Service Center - 04035479144258

No Description
BIOTRONIK SE & Co. KG
3.29
Not in Commercial Distribution

  • 04035479144258 ()
405553

  • Patient health record information system

Home Monitoring Service Center - 04035479144241

No Description
BIOTRONIK SE & Co. KG
3.28
In Commercial Distribution

  • 04035479144241 ()
405552

  • Patient health record information system

Home Monitoring Service Center - 04035479143848

No Description
BIOTRONIK SE & Co. KG
3.27
In Commercial Distribution

  • 04035479143848 ()
405331

  • Patient health record information system
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