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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 Synchro Repla:y Excellium 3.4 is a medical laser workstation equipped with an High power Alexandrite 755 nm laser and an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces.
EL.EN. SPA
M104K1
In Commercial Distribution

  • 08057017760108 ()
M104K1

  • Multi-modality skin surface treatment system
The smart US-20D system consists in a carbon dioxide laser (CO2) with 25W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079B1
In Commercial Distribution

  • 08057017760092 ()
M079B1

  • Dermatological carbon dioxide laser system
The Smartxide 50 system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079AL1
In Commercial Distribution

  • 08057017760085 ()
M079AL1

  • Dermatological carbon dioxide laser system
The Smartxide system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079R1
In Commercial Distribution

  • 08057017760078 ()
M079R1

  • Dermatological carbon dioxide laser system
The Smartfile medical system is a Nd:YAG laser device for treatment of dental desease. The laser radiation is delivered to the treatment area through the handpieces.
EL.EN. SPA
M077C2
Not in Commercial Distribution

  • 08057017760054 ()
M077C2

  • Dental solid-state laser system
The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitting laser radiation in three wavelenghts and includes a wide range of different delivery system, handpieces, fibers, cannulas and other accessories.
EL.EN. SPA
M094E1
In Commercial Distribution

  • 08057017760009 ()
M094E1

  • General/multiple surgical solid-state laser system
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host.
CARDIOLINE SPA
HD+
In Commercial Distribution

  • 08056732654594 ()
81018027

  • Multichannel electrocardiograph, signal-averaging
12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children. 4.3" display and 100mm printer paper.
CARDIOLINE SPA
ECG100+
In Commercial Distribution

  • 08056732653610 ()
80508095

  • Electrocardiograph, professional, multichannel
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth or USB, sends the data to the host.
CARDIOLINE SPA
HD+12
In Commercial Distribution

  • 08056732652422 ()
81018331

  • Electrocardiograph, professional, multichannel
ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only. It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.
ITALIAN ENGINEERING SRL
MD01
In Commercial Distribution

  • 08055510890087 ()

  • Weight: 5.8 Kilogram
  • Length: 38.5 Centimeter
  • Height: 10 Centimeter
  • Width: 20.5 Centimeter


  • Percutaneous radio-frequency ablation system generator
Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
ESSILOR INTERNATIONAL
VS01012
In Commercial Distribution

  • 03615020000687 ()


  • Phoropter, electric
Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL550L
In Commercial Distribution

  • 03615020000366 ()


  • Ophthalmic examination slit lamp
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL500L
In Commercial Distribution

  • 03615020000359 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300L
Not in Commercial Distribution

  • 03615020000281 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300H
Not in Commercial Distribution

  • 03615020000274 ()


  • Ophthalmic examination slit lamp
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
ESSILOR INTERNATIONAL
RETINA 400
In Commercial Distribution

  • 03615020000267 ()


  • Ophthalmic fundus camera
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis. It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm
ESSILOR INTERNATIONAL
ALM800
In Commercial Distribution

  • 03615020000236 ()


  • Automated lensmeter
Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15020-US
Not in Commercial Distribution

  • 03615220003471 ()


  • Electroencephalographic electrode cap, single-use
It enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802)
BIOSERENITY MEDICAL DEVICES GROUP
1001-15015-US
Not in Commercial Distribution

  • 03615220001781 ()


  • Electroencephalographic monitoring system
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01114
In Commercial Distribution

  • 03615020000724 ()


  • Phoropter, electric
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01014
In Commercial Distribution

  • 03615020000694 ()


  • Phoropter, electric
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01112
In Commercial Distribution

  • 03615020000663 ()


  • Phoropter, electric
3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
ESSILOR INTERNATIONAL
OCT2JT
In Commercial Distribution

  • 03615020000489 ()


  • Retinal optical coherence tomography system
Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
ESSILOR INTERNATIONAL
RET1IN
In Commercial Distribution

  • 03615020000465 ()


  • Ophthalmic fundus camera
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01012
In Commercial Distribution

  • 03615020000427 ()


  • Phoropter, electric
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL450L
Not in Commercial Distribution

  • 03615020000342 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL450H
Not in Commercial Distribution

  • 03615020000335 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL400L
Not in Commercial Distribution

  • 03615020000328 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL400H
Not in Commercial Distribution

  • 03615020000311 ()


  • Ophthalmic examination slit lamp
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