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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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Internal Hex FD
TERRATS MEDICAL SL.
58.040/2
In Commercial Distribution

  • 08435750405225 ()
ARDX-TBCNH4515

  • Dental implant suprastructure, permanent, preformed
Internal Hex FD
TERRATS MEDICAL SL.
58.038/2
In Commercial Distribution

  • 08435750405164 ()
ARDX-TBCNH3415

  • Dental implant suprastructure, permanent, preformed
Knee Orthosis (Gen.2)
Ambroise Holland B.V.
Genux 2
In Commercial Distribution

  • 08719327474433 ()


  • Custom-made lower-limb orthosis
The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M002-6A/2
In Commercial Distribution

  • 03830054237636 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M002-6A/2
Not in Commercial Distribution

  • 03830054230514 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M002-6A/2
Not in Commercial Distribution

  • 03830054230293 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system
"The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range. XP Focus family laser systems incorporate: A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation. An aiming semiconductor diode laser operating at a wavelength of 650 nm. The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length."
FOTONA d.o.o.
M001-14F 2
Not in Commercial Distribution

  • 03830054230231 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
"The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. "
FOTONA d.o.o.
M021-5AF/2
Not in Commercial Distribution

  • 03830054230095 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system
The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range of the electromagnetic spectrum. Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length. The Fotona QX MAX laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in general dermatology.
FOTONA d.o.o.
M031-3A/2
Not in Commercial Distribution

  • 03830054230064 ()


  • General/multiple surgical frequency-doubled solid-state laser system
  • Dermatological frequency-doubled solid-state laser system
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 2
In Commercial Distribution

  • 08718734961512 ()
  • 08718734961482 ()
221.002.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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