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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 Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
CEFLA SOCIETA' COOPERATIVA
X-VS E
In Commercial Distribution

  • 08033837936848 ()


  • Dental digital imaging sensor, intraoral
The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
CEFLA SOCIETA' COOPERATIVA
ZEN-X E
In Commercial Distribution

  • 08033837936817 ()


  • Dental digital imaging sensor, intraoral
The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment.
CEFLA SOCIETA' COOPERATIVA
C-U2
In Commercial Distribution

  • 08033837930174 ()
70220000

  • Intraoral camera
Perseus Device Sensor
ORTHOKEY ITALIA SRL
20100801
In Commercial Distribution

  • 08052675960013 ()
20100801

  • Orthopaedic stereotactic surgery system
No Description
NDD Medizintechnik AG
3100-1
In Commercial Distribution

  • 07640142190370 ()
3100-1

  • Pulmonary function analysis system, adult
No Description
NDD Medizintechnik AG
3000-1
In Commercial Distribution

  • 07640142190349 ()
3000-1

  • Pulmonary function analysis system, adult
No Description
NDD Medizintechnik AG
2700-3
In Commercial Distribution

  • 07640142190301 ()
2700-3

  • Diagnostic spirometer, professional
No Description
NDD Medizintechnik AG
2001-2
In Commercial Distribution

  • 07640142190059 ()
2001-2

  • Diagnostic spirometer, professional
No Description
NDD Medizintechnik AG
2001-1
In Commercial Distribution

  • 07640142190042 ()
2001-1

  • Diagnostic spirometer, professional
Breast Pump, electric, with hands-free-pumpset
Ardo medical AG
63.00.453
In Commercial Distribution

  • 07640108054470 ()
63.00.453

  • Breast pump, electric
  • Breast pump support kit, reusable
Breast Pump, electric, with carry bag
Ardo medical AG
63.00.511
In Commercial Distribution

  • 07640108053961 ()
63.00.511

  • Breast pump, electric
Breast Pump Double, electric
Ardo medical AG
63.00.510
In Commercial Distribution

  • 07640108053640 ()
63.00.510

  • Breast pump, electric
  • Breast pump support kit, reusable
Breast Pump, electric
Ardo medical AG
63.00.509
In Commercial Distribution

  • 07640108053541 ()
  • 07640108053534 ()
63.00.509

  • Breast pump, electric
Breast Pumps, electric, with cooling bag
Ardo medical AG
63.00.524
In Commercial Distribution

  • 07640108051516 ()
63.00.524

  • Breast pump, electric
EHOB Air Pump
EHOB INC
REV00
In Commercial Distribution

  • 10603354130439 ()
Z0156A1

  • Patient transfer system, manual
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Analog Output Cable
ST. JUDE MEDICAL, INC.
PN-001427
In Commercial Distribution

  • 07640157990217 ()
PN-001427

  • Electrical-only medical device connection cable, reusable
RF Cable
ST. JUDE MEDICAL, INC.
PN-004515
In Commercial Distribution

  • 07640157990064 ()
PN-004515

  • Electrical-only medical device connection cable, reusable
RF Cable
ST. JUDE MEDICAL, INC.
PN-004514
In Commercial Distribution

  • 07640157990057 ()
PN-004514

  • Electrical-only medical device connection cable, reusable
The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116I1
In Commercial Distribution

  • 08057017760511 ()
M116I1

  • Microwave hyperthermia system applicator, extracorporeal
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 2 optical fibres. The operator can use 1 to 2 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
EL.EN. SPA
M095G1
In Commercial Distribution

  • 08057017760504 ()
M095G1

  • General/multiple surgical diode laser system
The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.
EL.EN. SPA
M053Z1
In Commercial Distribution

  • 08057017760474 ()
M053Z1

  • General/multiple surgical solid-state laser system
The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
EL.EN. SPA
M122B1
In Commercial Distribution

  • 08057017760450 ()
M122B1

  • Multi-modality skin surface treatment system
The TIAC II is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116H1
In Commercial Distribution

  • 08057017760436 ()
M116H1

  • Microwave hyperthermia system applicator, extracorporeal
The TIAC 1 is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116E1
In Commercial Distribution

  • 08057017760405 ()
M116E1

  • Microwave hyperthermia system applicator, extracorporeal
The DEKA SmartXide² Trio is a medical laser system equipped with a 60W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.
EL.EN. SPA
M103AE1
In Commercial Distribution

  • 08057017760382 ()
M103AE1

  • General/multiple surgical solid-state/carbon dioxide laser system
The DEKA Motus AY is a medical device quipped with a 755nm and 1064nm solid state laser sources. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
EL.EN. SPA
M115B1
In Commercial Distribution

  • 08057017760344 ()
M115B1

  • Multi-modality skin surface treatment system
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
EL.EN. SPA
M095D1
In Commercial Distribution

  • 08057017760320 ()
M095D1

  • General/multiple surgical diode laser system
The Smartxide TETRA system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.
EL.EN. SPA
M118C1
In Commercial Distribution

  • 08057017760290 ()
M118C1

  • General/multiple surgical carbon dioxide laser system
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 60W of maximum power. It can be equipped with an optional diode laser source of 50W maximum power. The laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the Smartxide² system, having different spot sizes and high performances in specific application fields.
EL.EN. SPA
M103AC1
In Commercial Distribution

  • 08057017760283 ()
M103AC1

  • General/multiple surgical diode/carbon dioxide laser system
The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end. The DEKA SmartXide 2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces.
EL.EN. SPA
M103K1
In Commercial Distribution

  • 08057017760269 ()
M103K1

  • General/multiple surgical solid-state/carbon dioxide laser system
The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.The DEKA SmartXide² CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces.
EL.EN. SPA
M103J1
In Commercial Distribution

  • 08057017760252 ()
M103J1

  • General/multiple surgical solid-state/carbon dioxide 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
The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.
EL.EN. SPA
M117H1
In Commercial Distribution

  • 08057017760856 ()


  • Dermatological diode laser system
The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.
EL.EN. SPA
M126AC1
In Commercial Distribution

  • 08057017760818 ()


  • Multi-modality skin surface treatment system
The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are: - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm Q-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
EL.EN. SPA
M117B1
In Commercial Distribution

  • 08057017760733 ()
M117B1

  • Multi-modality skin surface treatment system
DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
EL.EN. SPA
M110F1
In Commercial Distribution

  • 08057017760726 ()


  • Dental carbon dioxide laser system
The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116H1
In Commercial Distribution

  • 08057017760719 ()
M116H1

  • Microwave hyperthermia system applicator, extracorporeal
The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)
EL.EN. SPA
M133A1
In Commercial Distribution

  • 08057017760665 ()
M133A1

  • General/multiple surgical diode/carbon dioxide laser system
The MultiPulse PRO 60 is a medical laser system equipped with a 60W CO2 laser source delivered through articulated arm.
EL.EN. SPA
M110Q1
In Commercial Distribution

  • 08057017760603 ()
M110Q1

  • General/multiple surgical solid-state/carbon dioxide laser system
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