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)
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
CNDT 200H12 CONTEGRA GBR1 HDE TEMP IND
MEDTRONIC, INC.
200H12
Not in Commercial Distribution

  • 00643169298644 ()

  • Valve Size 12 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200H14 CONTEGRA GBR1 HDE TEMP IND
MEDTRONIC, INC.
200H14
Not in Commercial Distribution

  • 00643169298637 ()

  • Valve Size 14 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200H16 CONTEGRA GBR1 HDE TEMP IND
MEDTRONIC, INC.
200H16
Not in Commercial Distribution

  • 00643169298620 ()

  • Valve Size 16 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200H18 CONTEGRA GBR3 HDE TEMP IND
MEDTRONIC, INC.
200H18
Not in Commercial Distribution

  • 00643169298613 ()

  • Valve Size 18 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200H20 CONTEGRA GBR3 HDE TEMP IND
MEDTRONIC, INC.
200H20
Not in Commercial Distribution

  • 00643169298606 ()

  • Valve Size 20 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200H22 CONTEGRA GBR3 HDE TEMP IND
MEDTRONIC, INC.
200H22
Not in Commercial Distribution

  • 00643169298590 ()

  • Valve Size 22 MM


  • Pulmonary open-surgery heart valve bioprosthesis
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