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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Pack includes: Ultra Thin Her Pleasure Ecstasy Ultra-Enz Comfort Thintensity
CHURCH & DWIGHT CO., INC.
00022600952978
In Commercial Distribution

  • 00022600952978 ()
  • 80022600952974 ()


  • Basic male condom, Hevea-latex
AIR STAIR ASSY NO MOD G 3-5 * (PLS) (WHEELCHAIR)
LIFEPORT, LLC
21-10040-01
In Commercial Distribution

  • 00810050862288 ()


  • Assistive automobile wheelchair/occupant lift
INSTALLATION, POWER LOADING SYSTEM, FALCON * PLS, WHEELCHAIR
LIFEPORT, LLC
21-10075-01
In Commercial Distribution

  • 00810050862172 ()


  • Assistive automobile wheelchair/occupant lift
INSTALLATION, RAIL ASSEMBLY, GLOBAL PLS * (WHEELCHAIR, PM)
LIFEPORT, LLC
21-10081-01
In Commercial Distribution

  • 00810050862035 ()


  • Assistive automobile wheelchair/occupant lift
Pack includes: Ultra Thin, Her Pleasure Ecstasy, Ultra ENZ and Thintensity.
CHURCH & DWIGHT CO., INC.
00022600001492
In Commercial Distribution

  • 00022600001492 ()
  • 80022600952974 ()


  • Basic male condom, Hevea-latex
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform
Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training.
BERTEC CORPORATION
97P-0072
In Commercial Distribution

  • 00850017250062 ()


  • Posturography system platform
Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0002
In Commercial Distribution

  • 00850017250055 ()


  • Posturography system platform
Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0001
In Commercial Distribution

  • 00850017250048 ()


  • Posturography system platform
Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0005
In Commercial Distribution

  • 00850017250031 ()


  • Posturography system platform
Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0066
In Commercial Distribution

  • 00850017250024 ()


  • Posturography system platform
Bertec Balance Advantage Essential Spark system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0077
In Commercial Distribution

  • 00850017250017 ()


  • Posturography system platform
Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with 4 load cells mounted between them. The vertical component of the total reaction force is measured independent of where it is applied over the surface of the plates. The relative light weight and small geometry of the plates aids in a wide range of upper and lower limb applications. The ForcePlates measure as little as the touch of a finger through to full standing weight bearing. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.
BIOMETRICS LIMITED
FP3
In Commercial Distribution

  • 05060481690089 ()


  • Posturography system platform
No Description
Balance Tracking Systems Incorporated
BTRACKS-50
In Commercial Distribution

  • 00860010129104 ()


  • Posturography system platform
VIDEOSTAR II is a binocular freefield videonystagmoscope device. It transcribes the image of both eyes on the computer screen. It helps to asses the reaction of the patient viewing his eyes and its nystagmus during testing. The device consists of a goggle equipped with two cameras and an infrared mirror that enables to record both eye's movement without denying patient's field of view a removable cover to set the patient in total darkness and software running on a computer.
Instrumentation Difra SA
VIDEOSTAR II
In Commercial Distribution

  • B516220920 ()
22092

  • Posturography system platform
The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video. Freefield videonystagmoscope digital USB2
Instrumentation Difra SA
VIDEOSTAR II
In Commercial Distribution

  • B51622092 ()
22092

  • Posturography system platform
VIDEOSTAR I is a monocular videonystagmoscope device. It transcribes the image of the patient's eye on the computer screen. It helps to asses the reaction of the patient viewing his eye and its nystagmus during testing. The device consists of a goggle that set the camera in front of the patient's eye and allows to occult the patient of the outside, a camera with an infrared lighting and a software running on a computer. The camera is place of the left or the right eye, the other one can either be let free or cover to deny patient's view.
Instrumentation Difra SA
VIDEOSTAR
In Commercial Distribution

  • B516220900 ()
22090

  • Posturography system platform
The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient's right or left eye. The camera is fixed on a mask, fitting the line of the patient's face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view. TECHNICAL SPECIFICATION: USB 2.0 connection 30 frames/s Resolution: 640 x 480 pixels Cable of 5 meters Compatible Windows Seven/8 - 32 or 64 bits
Instrumentation Difra SA
VIDEOSTAR
In Commercial Distribution

  • B51622090 ()
22090

  • Posturography system platform
No Description
SORIN GROUP ITALIA SRL
PC
In Commercial Distribution

  • 38033178104792 ()
  • 08033178104791 ()


  • Centrifugal circulatory assist pump, electric
No Description
SORIN GROUP ITALIA SRL
REVOLUTION
In Commercial Distribution

  • 38033178104778 ()
  • 08033178104777 ()


  • Centrifugal circulatory assist pump, electric
No Description
VIRTUALIS
MOT
In Commercial Distribution

  • 03760310780562 ()


  • Posturography system platform
No Description
VIRTUALIS
V1
In Commercial Distribution

  • 03760310780555 ()


  • Posturography system platform
SP PUMP HEAD ADAPTER
TERUMO CORPORATION
XX*SP03
In Commercial Distribution

  • 54987350734438 ()
  • 04987350734433 ()
XX*SP03

  • Centrifugal circulatory assist pump, electric
CAPIOX® SP PUMP
TERUMO CORPORATION
CX*SP45
In Commercial Distribution

  • 04987350706119 ()
  • 54987350706114 ()


  • Centrifugal circulatory assist pump, electric
45739
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 35099169457394 ()
  • 05099169457393 ()
  • 15099169457390 ()


  • Aerosol inhalation monitor
45738
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 35099169457387 ()
  • 05099169457386 ()
  • 15099169457383 ()


  • Aerosol inhalation monitor
45737
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 05099169457379 ()
  • 15099169457376 ()
  • 35099169457370 ()


  • Aerosol inhalation monitor
45735
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 05099169457355 ()
  • 15099169457352 ()
  • 35099169457356 ()


  • Aerosol inhalation monitor
45734
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 35099169457349 ()
  • 05099169457348 ()
  • 15099169457345 ()


  • Aerosol inhalation monitor
45733
VITALOGRAPH (IRELAND) LIMITED
4500
In Commercial Distribution

  • 35099169457332 ()
  • 05099169457331 ()
  • 15099169457338 ()


  • Aerosol inhalation monitor
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