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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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SIZER, ALLOGRAFT OATS 22.5MM
ARTHREX, INC.
AR-4080-225
In Commercial Distribution

  • 00888867032156 ()
AR-4080-225

  • Ligament graft sizer, noninvasive
SIZER, ALLOGRAFT OATS, 20 MM
ARTHREX, INC.
AR-4080-20
In Commercial Distribution

  • 00888867032149 ()
AR-4080-20

  • Ligament graft sizer, noninvasive
SIZER, ALLOGRAFT OATS, 18 MM
ARTHREX, INC.
AR-4080-18
In Commercial Distribution

  • 00888867032132 ()
AR-4080-18

  • Ligament graft sizer, noninvasive
SIZER, ALLOGRAFT OATS, 15 MM
ARTHREX, INC.
AR-4080-15
In Commercial Distribution

  • 00888867032118 ()
AR-4080-15

  • Ligament graft sizer, noninvasive
SIZER, ALLOGRAFT OATS, 14 MM
ARTHREX, INC.
AR-4080-14
In Commercial Distribution

  • 00888867032101 ()
AR-4080-14

  • Ligament graft sizer, noninvasive
SIZER, ALLOGRAFT OATS, 10 MM
ARTHREX, INC.
AR-4080-10
In Commercial Distribution

  • 00888867032095 ()
AR-4080-10

  • Ligament graft sizer, noninvasive
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software
EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.
MYCARDIUM AI LIMITED
01.01.00(USA)
In Commercial Distribution

  • 05061038730050 ()
EchoConfidence

  • Cardiac mapping system application software
GRAFT SIZER, 13 MM
Conmed Corporation
8743
In Commercial Distribution

  • 30845854025608 ()
  • 10845854025604 ()

  • Outer Diameter: 13 Millimeter
8743

  • Ligament graft sizer, noninvasive
No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software
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