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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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
No Description
Fujirebio Diagnostics, Inc.
801-905
Not in Commercial Distribution

  • 00869164000000 ()

  • Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests


  • Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)
Pulsar Vascular PulseRider,3.5 to 4.5mm,10mm,T shape
Medos International Sàrl
213-D
Not in Commercial Distribution

  • 00859030005123 ()
213-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 8 mm, Y Shape
Medos International Sàrl
303-D
Not in Commercial Distribution

  • 00859030005109 ()
303-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 10 mm, Y shape
Medos International Sàrl
311-D
Not in Commercial Distribution

  • 00859030005093 ()
311-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 10 mm, Y shape
Medos International Sàrl
313-D
Not in Commercial Distribution

  • 00859030005086 ()
313-D

  • Bare-metal intracranial vascular stent
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
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, T Shape
Medos International Sàrl
201-D
Not in Commercial Distribution

  • 00859030005154 ()
201-D

  • Bare-metal intracranial vascular stent
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