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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X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN L CEPH R
Not in Commercial Distribution

  • D804W09000090 ()
W0900009

  • Stationary panoramic/tomographic dental x-ray system, digital
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 10-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1790UVB-NB
In Commercial Distribution

  • B2191790UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1780UVB-NB
In Commercial Distribution

  • B2191780UVBNB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1760UVB-NB
In Commercial Distribution

  • B2191760UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-BROADBAND Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1760UVB
In Commercial Distribution

  • B2191760UVB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1740UVB-NB
In Commercial Distribution

  • B2191740UVBNB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-BROADBAND Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1740UVB
In Commercial Distribution

  • B2191740UVB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7184-02A
In Commercial Distribution

  • M90107RD718402A1 ()
  • M90107RD718402A0 ()

  • Length: 75 Millimeter
07RD7184-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
LUMIQUICK DIAGNOSTICS, INC.
07RD7093-11A
In Commercial Distribution

  • M90107RD709311A1 ()
  • M90107RD709311A0 ()

  • Length: 75 Millimeter
07RD7093-11A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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