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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
IPL3500
In Commercial Distribution
- 00074590550863 ()
- 10074590550860 ()
- 20074590550867 ()
0074590550863
- Cosmetic red-light phototherapy system, home-use
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
In Commercial Distribution
- 00628011941015 ()
101
- Indirect flat panel x-ray detector
The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro+
In Commercial Distribution
- 10860002280742 ()
- 00860002280745 ()
INSIGHT-PRO-PLUS
- Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro
In Commercial Distribution
- 10860002280735 ()
- 00860002280738 ()
INSIGHT-VIDEO-GOGGLES-PRO
- Eye/eyelid movement monitoring spectacles/goggles
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.
Vestibular First, LLC
Insight Disposable Cushions - 40-Count
In Commercial Distribution
- 00860002280714 ()
PART-DISPOSABLE-CUSHION-40CT
- Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution
- 10860002280704 ()
- 00860002280707 ()
- Vision/eye movement analysis system
SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable.
BEURER NORTH AMERICA, L.P.
SBM52
In Commercial Distribution
- 10853879007925 ()
- 00853879007928 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The BrainPort® V100 is an oral electronic vision aid that provides electrotactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog. It translates digital information from a video camera to gentle electrical stimulation patterns on the surface of the tongue.
WICAB, INC
V100
In Commercial Distribution
- 00862378000309 ()
DR-001062
- Video-camera translingual electrical stimulation system
Collimator, Manual Certified, 150kVp, LED 25W
COLLIMARE, LLC
CML-150-0001-C
In Commercial Distribution
- 00862005000306 ()
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV220
In Commercial Distribution
- 00865064000164 ()
- Wireless patient thermometer, reusable