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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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SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution

  • 00643169931329 ()


  • Neurological stereotactic surgery system
SFW KIT 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution

  • 00643169921917 ()


  • Neurological stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00643169838987 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00643169838970 ()


  • Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00643169838963 ()


  • Neurological stereotactic surgery system
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution

  • 09358140000055 ()
SCI0006

  • Radiological PACS software
Animal
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034090 ()
PLU235

  • Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034080 ()
PLU236

  • Radiology information system application software
Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
NIDEK CO.,LTD.
NAVIS-EX
In Commercial Distribution

  • 04987669100523 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution

  • 04987670105005 ()


  • Radiological PACS software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution

  • 05055272715744 ()


  • Ophthalmic examination slit lamp
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution

  • 00850005944508 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution

  • 00850005944355 ()
83-00093-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution

  • 00850005944119 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution

  • 00850005944089 ()
83-00054-000

  • Magnetic neural stimulation system
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000223 ()


  • Radiological PACS software
No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution

  • 00868579000216 ()


  • Radiological PACS software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution

  • 00860010709795 ()
VV-021

  • Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution

  • 00860010709788 ()


  • Perimeter, automatic
No Description
Virtual Vision Health
3.0.0
In Commercial Distribution

  • 00860010709757 ()


  • Perimeter, automatic
No Description
Virtual Vision Health
2.7.0
In Commercial Distribution

  • 00860010709740 ()


  • Perimeter, automatic
No Description
Virtual Vision Health
2.6.0
In Commercial Distribution

  • 00860010709733 ()


  • Perimeter, automatic
D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution

  • 00860009377615 ()


  • Endoscopic video image processing unit
D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM). The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization. Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge.
D-Scope Systems
6
In Commercial Distribution

  • 00860009377608 ()


  • Endoscopic video image processing unit
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