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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 iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution

  • 00860479001706 ()
Z2000

  • Corneal topography system
  • Automated ophthalmic refractometer
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
CENTERVUE SPA
RETIA 2
In Commercial Distribution

  • 08053677040086 ()
AINEUME002

  • Ophthalmic fundus camera
  • Scanning-laser retinal imaging system
A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution

  • 07290016986099 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MT-220 (Balloon Blast)
In Commercial Distribution

  • 07290016986082 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MC-320 (Color Match)
In Commercial Distribution

  • 07290016986075 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
No Description
Edan Instruments, Inc.
SA-05
In Commercial Distribution

  • 06944413812673 ()
  • 06944413812611 ()


  • Blood pressure ambulatory recorder
No Description
Edan Instruments, Inc.
SA-06
In Commercial Distribution

  • 06944413812666 ()
  • 06944413812604 ()


  • Blood pressure ambulatory recorder
No Description
Edan Instruments, Inc.
SA-09
In Commercial Distribution

  • 06944413812697 ()
  • 06944413812581 ()


  • Blood pressure ambulatory recorder
No Description
Edan Instruments, Inc.
SA-10
In Commercial Distribution

  • 06944413812680 ()
  • 06944413812574 ()


  • Blood pressure ambulatory recorder
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