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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INS 3116 ENTERRA eMANUAL
MEDTRONIC, INC.
3116
In Commercial Distribution

  • 00643169174993 ()


  • Gastric electrical stimulation system
LEAD 3391S-40 PSYCH DBS OCD HDE EMAN
MEDTRONIC, INC.
3391S-40
Not in Commercial Distribution

  • 00643169313552 ()

  • Length: 40.0 Centimeter


  • Deep brain electrical stimulation system
LEAD 4351-35 ENTERRA GASTRIC EMAN FWU
MEDTRONIC, INC.
4351-35
In Commercial Distribution

  • 00643169936577 ()

  • Length: 35.0 Centimeter


  • Gastric electrical stimulation system
LEAD 4351-35 ENTERRA GASTRIC EMAN FWU
MEDTRONIC, INC.
4351-35
In Commercial Distribution

  • 00643169887589 ()


  • Gastric electrical stimulation system
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
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
In Commercial Distribution



  • Microwave hyperthermia system
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
In Commercial Distribution



  • Microwave hyperthermia system
PulseRider Aneurysm Neck Reconstruction Device Connection Cable
Medos International Sàrl
PRDSACD
Not in Commercial Distribution

  • 00859030005260 ()
PRDSACD

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller
Medos International Sàrl
PRDSCBD
Not in Commercial Distribution

  • 00859030005253 ()
PRDSCBD

  • Vascular implant detacher, electronic, reusable
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