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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Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.
INSIGHTEC LTD
4000 Type 1.1
In Commercial Distribution

  • 07290019402558 ()
SYS004000-CA

  • Ultrasonic hyperthermia system
3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-102
In Commercial Distribution

  • 10190752200760 ()
770630-102

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-103
In Commercial Distribution

  • 10190752200746 ()
770630-103

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Ventilator breathing circuit, single-use
3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-103
Not in Commercial Distribution

  • 10190752155411 ()
770630-103

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Ventilator breathing circuit, single-use
3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-102
Not in Commercial Distribution

  • 10190752155404 ()
770630-102

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
3100B Disposable Items Kit / F&P 850
VYAIRE MEDICAL, INC.
775855
In Commercial Distribution

  • 10190752158825 ()
775855

  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
  • Carpal lunate prosthesis
3100B Disposable Items Kit / F&P 730
VYAIRE MEDICAL, INC.
775854
In Commercial Distribution

  • 10190752158818 ()
775854

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
3100B Disposable Items Kit / HRCI
VYAIRE MEDICAL, INC.
775853
In Commercial Distribution

  • 10190752158801 ()
775853

  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
Indications for FH: The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA CORPORATION
LA-15
In Commercial Distribution

  • 24993478010117 ()
  • 14993478010110 ()
  • 04993478010113 ()
N/A

  • Haemoperfusion system absorption column
No Description
TORAY INDUSTRIES,INC.
PTMC-28
In Commercial Distribution

  • 14960685200047 ()

  • Balloon Diameter Range: 24-28 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
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