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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COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-G
In Commercial Distribution

  • D0692502MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC
In Commercial Distribution

  • D0692502MCC0 ()


  • Dental delivery system
STEEL, ELECTRIC, THREE SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, ADJUSTABLE FOOT SECTION, SIDE PANEL, AND CASTERS
ARMEDICA MANUFACTURING CORP.
LAM350
In Commercial Distribution

  • B866MLAM3501 ()
  • B866PLAM3501 ()
LAM350

  • Examination/treatment table, line-powered
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the left
DE GÖTZEN SRL
XMT PAN 3D L
Not in Commercial Distribution

  • D804W09000100 ()
W0900010

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right
DE GÖTZEN SRL
XMT PAN 3D R
Not in Commercial Distribution

  • D804W09000040 ()
W0900004

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent
T2 BIOSYSTEMS, INC.
90-11400
In Commercial Distribution

  • M70890114000 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
First Source, Inc.
V5
In Commercial Distribution

  • G221200CA3080 ()
200-CA-308

  • Radiology DICOM image processing application software
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 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
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