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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
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