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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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Iris - 00886874117538

User Software
INTUITIVE SURGICAL, INC.
610040
In Commercial Distribution

  • 00886874117538 ()


  • Image segmentation application software

OrthoNext™ Platform System Software - 18053340345675

ORTHONEXT SOFTWARE
ORTHOFIX SRL
2.0
In Commercial Distribution

  • 18053340345675 ()
ORTHONEXTSW

  • Radiological PACS software

ZephyrLIFE Hospital - 10884521712904

ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution

  • 10884521712904 ()
Software Hospital

  • Electrosurgical return electrode, single-use

ZephyrLIFE Home - 10884521712898

ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution

  • 10884521712898 ()
Software Home

  • Electrosurgical return electrode, single-use

MLCL Client Software - 00195278507525

Software Medical Device GE Client Software V8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507525 ()
5889605

  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

MLCL Client Software - 00195278931504

Software Medical Device GE Client Software V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278931504 ()
5973597

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

GE Client Software - 00840682145763

Software Medical Device GE Client Software V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145763 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

VisionX - E247E7300

Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software

DBSWIN - E247E7200A0

Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • General-purpose dental x-ray system application software

ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT - 04953170360824

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software
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