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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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An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Solio Alfa +
In Commercial Distribution

  • 07290017992006 ()
  • 17290017992003 ()
  • 27290017992000 ()
7290017992006

  • Medium-wave diathermy treatment system generator
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
BellaGlide
In Commercial Distribution

  • 07290016627381 ()
  • 27290016627385 ()
  • 17290016627388 ()
7290016627381

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go Compact
In Commercial Distribution

  • 07290015418461 ()
  • 27290015418465 ()
  • 17290015418468 ()
7290015418461

  • Cosmetic red-light phototherapy system, home-use
ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
HOME SKINOVATIONS LTD
ToothWave US
In Commercial Distribution

  • 07290112451675 ()
  • 17290112451672 ()
  • 27290112451679 ()
7290112451675

  • Radio-frequency toothbrush
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go LUXX Mini-Spa
In Commercial Distribution

  • 27290112450559 ()
  • 17290112450552 ()
  • 07290112450555 ()
7290112450555

  • Cosmetic red-light phototherapy system, home-use
No Description
HOME SKINOVATIONS LTD
Tightra NA
In Commercial Distribution

  • 07290112450067 ()
  • 17290112450064 ()
  • 37290112450068 ()
  • 27290112450061 ()
7290112450067

  • Penile sexual vibrator
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The EyeBOX device tracks a patient’s eye movement and calculates a BOX Score ranging from 0-20. A score of less than 10 is a negative result, while a score of greater than or equal to 10 indicates a positive result.
Oculogica Inc.
OCL 02.5
In Commercial Distribution

  • 00810051680003 ()


  • Eye-tracking neurological/brain injury assessment device
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