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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Stent System
Stryker Corporation
M003WS0250150
In Commercial Distribution

  • 04546540722775 ()

  • Length: 15.0 Millimeter
  • Outer Diameter: 2.5 Millimeter
M003WS0250150

  • Bare-metal intracranial vascular stent
Stent System
Stryker Corporation
M003WS0250090
In Commercial Distribution

  • 04546540722768 ()

  • Length: 9.0 Millimeter
  • Outer Diameter: 2.5 Millimeter
M003WS0250090

  • 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
Temporary percutaneous transluminal cerebral artery dilation device.
Vesalio
VS-4022-F1RR
In Commercial Distribution

  • 00851279008767 ()
VS-4022-F1RR

  • Thrombectomy suction catheter
Deep Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-2000U
Not in Commercial Distribution

  • 00851551005187 ()


  • Tumour-therapy radio-frequency hyperthermia system
Deep Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-2000B
Not in Commercial Distribution

  • 00851551005170 ()


  • Tumour-therapy radio-frequency hyperthermia system
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
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