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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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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 - 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

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

ELI Edit - 00817655022802

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system

ELI Edit - 00817655022796

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system

E-Scribe - 00817655021270

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-BAA-BXXXX
Not in Commercial Distribution

  • 00817655021270 ()


  • Patient health record information system

E-Scribe - 00817655020617

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-DAACA
Not in Commercial Distribution

  • 00817655020617 ()


  • Patient health record information system

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020490

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020209

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Exa - 00817100020193

EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation

E-Scribe - 00812345027785

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-FAA-BXXXX
Not in Commercial Distribution

  • 00812345027785 ()


  • Patient health record information system

E-Scribe - 00812345027778

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-EAA-BXXXX
Not in Commercial Distribution

  • 00812345027778 ()


  • Patient health record information system

E-Scribe - 00812345027761

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXACB
Not in Commercial Distribution

  • 00812345027761 ()


  • Patient health record information system

E-Scribe - 00812345027754

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-FAACB
Not in Commercial Distribution

  • 00812345027754 ()


  • Patient health record information system

E-Scribe - 00812345027747

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXXXX
Not in Commercial Distribution

  • 00812345027747 ()


  • Patient health record information system

E-Scribe - 00812345027730

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-AAB-CXXXA
Not in Commercial Distribution

  • 00812345027730 ()


  • Patient health record information system

ELI Edit - 00812345025217

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system

ELI Edit - 00812345023459

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system

SICAT Air - B06965436510

No Description
HiCat GmbH
6543651
In Commercial Distribution

  • B06965436510 ()


  • 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

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

UDM (Urinalysis Data Manager) - 04987562488506

No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system

PTS Connect™ Universal Solution - 00381933771015

The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.
POLYMER TECHNOLOGY SYSTEMS, INC.
3771
In Commercial Distribution

  • 00381933771015 ()
3771

  • Clinical laboratory information system
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