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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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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

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

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

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

Cardea SOLO - 00857553006139

Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution

  • 00857553006139 ()
D300

  • Electrocardiographic ambulatory recorder

Natus - 00382830061971

Software Upgrade from v22 to Natus Elite Software
NATUS NEUROLOGY INCORPORATED
033418
In Commercial Distribution

  • 00382830061971 ()


  • Electromyograph

miPlatform - 06970901070010

No Description
Hinacom Software and Technology, Ltd.
V2.0
In Commercial Distribution

  • 06970901070010 ()


  • Radiological PACS software

BIS module (w accessory kit) - 06944904096728

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046969-00
In Commercial Distribution

  • 06944904096728 ()


  • Analytical scalp electrode, single-use
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