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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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Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046969-00
In Commercial Distribution

  • 06944904096728 ()


  • Analytical scalp electrode, single-use
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 90884521657515 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 20884521134505 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD
The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool. IMAGE-ARENA is not intended to be used for reading of mammography images.
TOMTEC Imaging Systems GmbH
IA4
Not in Commercial Distribution

  • 04260361440150 ()


  • Radiological PACS software
spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies.
ONEFIT MEDICAL
1.x
In Commercial Distribution

  • 03700757200858 ()


  • Orthopaedic/craniofacial implantation planning software
The Automatic Registration - is a software module, that when used with a compatible computer workstation and compatible registration accessories provides a “registration” for subsequent navigation applications.
Brainlab AG
2.6
In Commercial Distribution

  • 04056481145101 ()


  • Electromagnetic/optical surgical navigation device tracking system
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
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.5.0
Not in Commercial Distribution

  • 03770019599020 ()


  • Radiological PACS software
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