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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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The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution

  • B201CGOH1 ()
  • B201CGOH0 ()
CG-OH

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CSM2050 Software
In Commercial Distribution

  • B595CSM20500 ()
CSM2050

  • Centralized patient monitor
  • Cardiac arrhythmia monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
  • Pulse oximeter
  • Clinical management support software
Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 22-24 Inch Heavy Duty Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2HDCA
In Commercial Distribution

  • 20885632142557 ()
  • 10885632142550 ()


  • Wheelchair wheel
No Description
MITAKA KOHKI CO., LTD.
KV3
In Commercial Distribution

  • 04589698450602 ()


  • General-purpose surgical microscope
  • Neurosurgical microscope
  • Video camera surgical microscope system
  • Microscope video camera
  • ENT surgical microscope
  • Surgical microscope fluorescent angiography system
  • Surgical microscope video camera, non-sterilizable
  • Medical video image recorder
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD
Elite Heavy-Duty Back Support. (3" contour depth; 500lb weight capacity). HD mounting hardware included. Matrx Elite backs are designed to provide precise orientation within the wheelchair for optimal postural support.
Motion Concepts Inc
PBE-HD
In Commercial Distribution

  • 07540147000158 ()
PBEwwhh-HD

  • Wheelchair back rest
IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as, but not limited to, CT and MRI, or from image archives. IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838125940 ()
837509

  • Radiology picture archiving and communication system workstation
Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Healthcare Informatics, Inc.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838091849 ()
837509

  • Radiology picture archiving and communication system workstation
Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
8.x
In Commercial Distribution

  • 00884838074804 ()
837509

  • Radiology picture archiving and communication system workstation
Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.
NCS LAB SRL
SHWM01SW1
In Commercial Distribution

  • 08051122041091 ()


  • Biomechanical function analysis/rehabilitation software
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