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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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This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-600WL v2
In Commercial Distribution

  • 04547410337396 ()
  • 14547410337393 ()


  • Flexible video colonoscope, reusable
The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates.
FUJIFILM CORPORATION
POSITIONER KIT BPY-L HA USA E
In Commercial Distribution

  • 04547410336047 ()


  • Stationary mammographic x-ray system, digital
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE A E
In Commercial Distribution

  • 04547410335286 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2623J -N20-
In Commercial Distribution

  • 04547410334999 ()
  • 14547410334996 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2623J -N15-
In Commercial Distribution

  • 04547410334982 ()
  • 14547410334989 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N15-
In Commercial Distribution

  • 04547410334548 ()
  • 14547410334545 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N10-
In Commercial Distribution

  • 04547410334531 ()
  • 14547410334538 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -B30-
In Commercial Distribution

  • 04547410334524 ()
  • 14547410334521 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -B25-
In Commercial Distribution

  • 04547410334517 ()
  • 14547410334514 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TY-06D
In Commercial Distribution

  • 04547410332100 ()


  • Medical air low pressure hose
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