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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No Description
REFLEXION HEALTH, INC.
3.3.2-2.13.0
In Commercial Distribution

  • 00860001498400 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Verity XR EnGauge Physical Rehabilitation System is an Extended Reality software platform that augments physical rehabilitation through exercise gamification incorporating biofeedback, kinematic data reporting, and immersive learning. The EnGauge Physical Rehabilitation System software readily integrates with existing Extended Reality hardware and peripherals to provide an integrated physical rehabilitation system.
Verity Technologies, Inc.
VXRE-01
In Commercial Distribution

  • 00860008232304 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
A software system used with the Microsoft Kinect intended to be used to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audiovisual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional.
VIRTUAL THERAPY SOLUTIONS, LLC.
SaeboVR-1
In Commercial Distribution

  • 00863090000400 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
No Description
VIRTUSENSE TECHNOLOGIES, INC.
v2024-01Jan-11-e940.json
In Commercial Distribution

  • 00860011881704 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
ASSEMBLY PKGD LIPIVIEW-2 - US
TEARSCIENCE, INC.
LVI-2000
In Commercial Distribution

  • 00859623006612 ()
100100

  • Meibomian gland camera/ophthalmic interferometer
Virtual display rehabilitation system
ACCELERATED CARE PLUS CORP
300600C
In Commercial Distribution

  • 00858703006351 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Interactive cycling therapy feedback device.
ACCELERATED CARE PLUS CORP
300800T
In Commercial Distribution

  • 00858703006382 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Reflex is a rehabilitative exercise device that fits to the lower limb and is intended to facilitate knee stretching and strengthening exercises and perform measurement functions for rehabilitation related to musculoskeletal pathologies, injury, and/or surgery of the knee. Reflex is intended to be used in a clinical or home environment.
Assistive Technology Development, Inc.
KN33-LE
In Commercial Distribution

  • 00860013061104 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
MRI Wireless Multi-Gas Unit w/O2
IRADIMED CORP.
3886
In Commercial Distribution

  • 00856038001225 ()
3886

  • Anaesthetic agent gas monitor, multiple
No Description
HOCOMA AG
Motion
Not in Commercial Distribution

  • 07640174660261 ()
31081

  • Virtual-display rehabilitation system, non-supportive, clinical
The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data. The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply.
MYOTRONICS NOROMED, INC
MES 9000 EMG
In Commercial Distribution

  • D792N9200A0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions. The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool.
MYOTRONICS NOROMED, INC
NT360
In Commercial Distribution

  • D792N9360A0 ()
  • D792N36010 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art. The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface. The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes: Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are: •A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial.
MYOTRONICS NOROMED, INC
Muscle Tester
In Commercial Distribution

  • D792N9600A0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
ARIA HOME PT SOFTWARE
Smith & Nephew, Inc.
SSK1
In Commercial Distribution

  • 00885556803868 ()
SSK1

  • Virtual-display rehabilitation system, non-supportive, clinical
No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Gas Sample Line Set
In Commercial Distribution

  • EMIP54000171 ()
  • EMIP54000170 ()
5400017

  • Anaesthetic agent gas monitor, multiple
The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. • Interferometry: records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value; • Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus; • NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value; • Fluorescein BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of the fluorescein in the patient’s eye (invasive) and without cone; • Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale; • Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry. All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
Shenzhen CERTAINN Technology Co., Ltd.
DEA
In Commercial Distribution

  • 06972039971641 ()


  • Meibomian gland camera/ophthalmic interferometer
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2308
In Commercial Distribution

  • 04953170396113 ()
N5769940

  • Surgical microscope video camera filter switch
Wound Cleanser No-rinse, non-irritating formulation Non-ionic surfactant Directions for use: 1. Turn nozzle to stream or spray position. 2. Spray contents on area to be cleansed approximately 3 inches away. Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl urea Indications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds. Caution: For external use only. Keep this and all similar products out of the reach of children. Store at ambient temperature.
Cardinal Health 200, LLC
WC8OZ
In Commercial Distribution

  • 10888499001343 ()
  • 00888499001346 ()
  • 00885380171867 ()
WC8OZ

  • Skin detergent
Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
B59800
Not in Commercial Distribution

  • 10310819000472 ()
  • 00310819000475 ()

  • Width: 1.2 Inch
  • Length: 2.6 Inch
B59800

  • Skin degreaser
Stapler Skin Disposable 35R
HENRY SCHEIN, INC.
9009734
In Commercial Distribution

  • 10304040029098 ()
  • 00304040029091 ()
  • 20304040029095 ()

  • Length: 5.9 Millimeter
9009734

  • Skin stapler
SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
OPUS KSD, INC.
404010
In Commercial Distribution

  • 00867469000206 ()
  • 10867469000203 ()


  • Skin stapler
No Description
AVID MEDICAL, INC.
YNHN044-01_0001
In Commercial Distribution

  • 20809160036676 ()
  • 10809160036679 ()


  • Skin allograft
No Description
AVID MEDICAL, INC.
LISH018_0014
In Commercial Distribution

  • 10809160210123 ()
LISH018

  • Skin allograft
Lemon Glycerin Swabsticks (3’s) ORAL | PREMOISTENED | STERILE
MCKESSON MEDICAL-SURGICAL INC.
989
In Commercial Distribution

  • 20612479209002 ()
  • 10612479208992 ()
  • 40612479209013 ()
  • 00612479236752 ()


  • Skin degreaser
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Nellcor Thermometer Filac
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Filac
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Nellcor Thermometer Filac
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Filac
Philips North America LLC
SL-VP-NIBPAH-MON-HW
In Commercial Distribution



  • Patient monitoring system module, interfacing
Vitals Plus Backpack Thermometer Exergen Capno Masimo
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002425 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002388 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002371 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Thermometer Exergen Capno Masimo
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002302 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002265 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040002258 ()


  • Patient monitoring system module, interfacing
Vitals Plus Backpack Thermometer Exergen Capno Masimo
Philips North America LLC
CAP-VP-NIBPAH-MON-HW
In Commercial Distribution

  • 03615040001978 ()


  • Patient monitoring system module, interfacing
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