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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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MiVu Balloon
DIVERSATEK HEALTHCARE, INC.
MI-BAL-01
In Commercial Distribution

  • 00816734022481 ()

  • Balloon Diameter: 20 Millimeter
MI-BAL-01

  • Manometric gastrointestinal motility analysis system
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
40009
In Commercial Distribution

  • 00856571007104 ()
40009

  • Virtual bronchoscopic navigation PACS software
1 Shot Phantom Plus is used for quality control of digital Radiography systems.
FUJIFILM CORPORATION
FCR 1SHOT PHANTOM PLUS MDR E
In Commercial Distribution

  • 04547410538861 ()


  • General-purpose diagnostic x-ray phantom, test object
No Description
DIERS International GmbH
0.5
In Commercial Distribution

  • 04260242060071 ()


  • Body-surface pressure mapping system
The telemetric medilogic seat pressure measurement using a flexible measuring mat, which is placed posterior under the patient while seating, enables wireless measurement of the pressure distribution with dynamic or static reading. The pressure values are sent wirelessly to the computer and displayed there on the monitor.
T & T medilogic Medizintechnik GmbH
medilogic seat pressure measurement
In Commercial Distribution

  • 04260718630036 ()


  • Body-surface pressure mapping system
The telemetric medilogic pressure distribution measurement system using pressure measurement insoles enables wireless measurement of pressure distribution occurring on the patient's foot while walking and standing. The pressure values in the shoe are sent wireless to the computer and displayed there on the monitor.
T & T medilogic Medizintechnik GmbH
medilogic foot pressure measuring insoles
In Commercial Distribution

  • 04260718630029 ()


  • Body-surface pressure mapping system
medilogic platform NX, consisting of a variable number of elements, is used to evaluate movement behavior during walking or standing. For this purpose, the load under the sole of the foot is indicated by color gradations and evaluated in relation to the curve of the body's center of pressure.
T & T medilogic Medizintechnik GmbH
medilogic pressure measuring platform NX
In Commercial Distribution

  • 04260718630012 ()


  • Body-surface pressure mapping system
The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
OH000010
In Commercial Distribution

  • 10185571000554 ()


  • Medical networking interface unit
Active Breathing Coordinator
ELEKTA LIMITED
1504204
In Commercial Distribution

  • 05060191071277 ()


  • Real-time position management respiratory gating system, optical
TotalExam® Lite & Oto 2.0 Camera Kit, Includes General Exam and Otoscope.
Globalmed Holdings, LLC
GMD5505HD20
In Commercial Distribution

  • 00850033167047 ()
GMD5505HD20

  • Multi-purpose digital medical camera
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