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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PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, Y shape
Medos International Sàrl
301-D
Not in Commercial Distribution

  • 00859030005116 ()
301-D

  • Bare-metal intracranial vascular stent
SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)
Edwards Lifesciences LLC
9630PL29A
In Commercial Distribution

  • 00690103210873 ()

  • Balloon Diameter: 29.0000 Millimeter
9630PL29A

  • Pulmonary transcatheter heart valve bioprosthesis
ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM
Edwards Lifesciences LLC
29AP4045
In Commercial Distribution

  • 00690103210866 ()
29AP4045A

  • Pulmonary transcatheter heart valve bioprosthesis
FENIX Beaded Sizer
Torax Medical, Inc.
FXBS
Not in Commercial Distribution

  • 00855106005547 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[20]
Not in Commercial Distribution

  • 00855106005530 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[19]
Not in Commercial Distribution

  • 00855106005523 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[18]
Not in Commercial Distribution

  • 00855106005516 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[17]
Not in Commercial Distribution

  • 00855106005509 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[16]
Not in Commercial Distribution

  • 00855106005493 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[15]
Not in Commercial Distribution

  • 00855106005486 ()


  • Anal sphincter prosthesis
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