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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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DataTrak Software
Thermogenesis Corp.
150040
In Commercial Distribution

  • 00886368000841 ()


  • Blood centrifugation system containment kit
User Software
INTUITIVE SURGICAL, INC.
610040
In Commercial Distribution

  • 00886874117538 ()


  • Image segmentation application software
ORTHONEXT SOFTWARE
ORTHOFIX SRL
2.0
In Commercial Distribution

  • 18053340345675 ()
ORTHONEXTSW

  • Radiological PACS software
ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution

  • 10884521712904 ()
Software Hospital

  • Electrosurgical return electrode, single-use
ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution

  • 10884521712898 ()
Software Home

  • Electrosurgical return electrode, single-use
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
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
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
Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software
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
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software
Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution

  • 00857553006139 ()
D300

  • Electrocardiographic ambulatory recorder
Software Upgrade from v22 to Natus Elite Software
NATUS NEUROLOGY INCORPORATED
033418
In Commercial Distribution

  • 00382830061971 ()


  • Electromyograph
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution

  • 05060496770011 ()


  • Blood bank information system application software
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution

  • 05060496770004 ()


  • Blood bank information system application software
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053713-00
In Commercial Distribution

  • 06936415905569 ()


  • General-purpose multi-parameter bedside monitor
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046969-00
In Commercial Distribution

  • 06944904096728 ()


  • Analytical scalp electrode, single-use
No Description
Neurowave Systems Inc.
NS-901
In Commercial Distribution

  • B746NS90101 ()


  • Anaesthesia depth monitor
SedLine Module
MASIMO CORPORATION
4497
In Commercial Distribution

  • 00843997013895 ()
4497

  • Patient monitoring system module, electroencephalographic
SedLine Module
MASIMO CORPORATION
4432
In Commercial Distribution

  • 00843997013475 ()
4432

  • Patient monitoring system module, electroencephalographic
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