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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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PWDII50SF K4 XHD127 SAX1216
MAQUET SAS
ARDPWT639199A
In Commercial Distribution

  • 03700712427207 ()


  • Operating room light
PWDII50DF K4 MHS019 SAX1216
MAQUET SAS
ARDPWT639197A
In Commercial Distribution

  • 03700712427191 ()


  • Operating room light
PWDII50DF K4 XHS021 SAX1216
MAQUET SAS
ARDPWT639196A
In Commercial Distribution

  • 03700712427184 ()


  • Operating room light
PWDII50DF K4 XHS016 SAX1216
MAQUET SAS
ARDPWT639195A
In Commercial Distribution

  • 03700712427177 ()


  • Operating room light
PWDII50DF K4 XHD127 SAX1216
MAQUET SAS
ARDPWT639194A
In Commercial Distribution

  • 03700712427160 ()


  • Operating room light
PWDII70DF K3 SC05 SAX1216
MAQUET SAS
ARDPWT639193A
In Commercial Distribution

  • 03700712427153 ()


  • Operating room light
PWDII70SF K3 MHS019 SAX1216
MAQUET SAS
ARDPWT639191A
In Commercial Distribution

  • 03700712427146 ()


  • Operating room light
PWDII70SF K3 XHS021 SAX1216
MAQUET SAS
ARDPWT639190A
In Commercial Distribution

  • 03700712427139 ()


  • Operating room light
PWDII70SF K3 XHS016 SAX1216
MAQUET SAS
ARDPWT639189A
In Commercial Distribution

  • 03700712427122 ()


  • Operating room light
PWDII70SF K3 XHD127 SAX1216
MAQUET SAS
ARDPWT639188A
In Commercial Distribution

  • 03700712427115 ()


  • Operating room light
PWDII70DF K3 MHS019 SAX1216
MAQUET SAS
ARDPWT639186A
In Commercial Distribution

  • 03700712427108 ()


  • Operating room light
PWDII70DF K3 XHS021 SAX1216
MAQUET SAS
ARDPWT639185A
In Commercial Distribution

  • 03700712427092 ()


  • Operating room light
PWDII70DF K3 XHS016 SAX1216
MAQUET SAS
ARDPWT639184A
In Commercial Distribution

  • 03700712427085 ()


  • Operating room light
PWDII70DF K3 XHD127 SAX1216
MAQUET SAS
ARDPWT639183A
In Commercial Distribution

  • 03700712427078 ()


  • Operating room light
PWDII50SF K3 MHS019 SAX1216
MAQUET SAS
ARDPWT639181A
In Commercial Distribution

  • 03700712427030 ()


  • Operating room light
PWDII50SF K3 XHS016 SAX1216
MAQUET SAS
ARDPWT639180A
In Commercial Distribution

  • 03700712427023 ()


  • Operating room light
PWDII50SF K3 XHS016 SAX1216
MAQUET SAS
ARDPWT639179A
In Commercial Distribution

  • 03700712427016 ()


  • Operating room light
PWDII50SF K3 XHD127 SAX1216
MAQUET SAS
ARDPWT639178A
In Commercial Distribution

  • 03700712427009 ()


  • Operating room light
PWDII50DF K3 MHS019 SAX1216
MAQUET SAS
ARDPWT639176A
In Commercial Distribution

  • 03700712426996 ()


  • Operating room light
PWDII50DF K3 XHS021 SAX1216
MAQUET SAS
ARDPWT639175A
In Commercial Distribution

  • 03700712426989 ()


  • Operating room light
PWDII50DF K3 XHS016 SAX1216
MAQUET SAS
ARDPWT639174A
In Commercial Distribution

  • 03700712426972 ()


  • Operating room light
PWDII50DF K3 XHD127 SAX1216
MAQUET SAS
ARDPWT639173A
In Commercial Distribution

  • 03700712426965 ()


  • Operating room light
PWDII77SF CL K4 XHS021 SAX081012
MAQUET SAS
ARDPWT639169A
In Commercial Distribution

  • 03700712426941 ()


  • Operating room light
PWDII77SF CL K4 XHS016 SAX081012
MAQUET SAS
ARDPWT639168A
In Commercial Distribution

  • 03700712426934 ()


  • Operating room light
G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s eyewear in order to allow the illumination of the oral cavity during oral examination, characterized by an excitation band from 440 to 490 nm.
PIERREL SPA
G.o.c.c.l.e.s. light
In Commercial Distribution

  • 08051040582010 ()
531000611

  • Oral lesion examination light
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.
DEKA M.E.L.A. SRL
M126AB1
In Commercial Distribution

  • 08034108512532 ()


  • Multi-modality skin surface treatment system
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

  • 08033837936855 ()


  • 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
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
Imaging System
LIGHTLAB IMAGING, INC.
900-700-00
In Commercial Distribution

  • 00183739000630 ()
900-700-00

  • Coronary optical coherence tomography system
Perseus Device Sensor
ORTHOKEY ITALIA SRL
20100801
In Commercial Distribution

  • 08052675960013 ()
20100801

  • Orthopaedic stereotactic surgery system
The MOTUS PRO AX is a medical laser equipped with Alexandrite 755nm laser only. The laser sources deliver 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.
DEKA M.E.L.A. SRL
M130P1
In Commercial Distribution

  • 08034108512907 ()


  • Multi-modality skin surface treatment system
The MOTUS PRO is a medical laser equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver 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.
DEKA M.E.L.A. SRL
M130N1
In Commercial Distribution

  • 08034108512891 ()


  • Multi-modality skin surface treatment system
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.
DEKA M.E.L.A. SRL
M118G1
In Commercial Distribution

  • 08034108512808 ()


  • General/multiple surgical carbon dioxide laser system
The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues incluing intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
DEKA M.E.L.A. SRL
M079BI1
In Commercial Distribution

  • 08034108512709 ()
M079R1

  • Dermatological carbon dioxide laser system
The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completiomn of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider wine and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of psuedo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the competition of a treatment regime. The Skintel Reader is intended as an onbjective measurement tool for examing skin melanin content for determing and setting a test spot starting fluence.
DEKA M.E.L.A. SRL
M122K1
In Commercial Distribution

  • 08034108512655 ()
M122K1

  • Multi-modality skin surface treatment system
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and 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.
DEKA M.E.L.A. SRL
M126AA1
In Commercial Distribution

  • 08034108512525 ()


  • Multi-modality skin surface treatment system
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
I-MAX 3D CEPH version
OWANDY RADIOLOGY
I-MAX 3D PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651828 ()
9304301011

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX 3D PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX 3D PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651804 ()
9304100011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital
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