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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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FFR Link - 08714729939603

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100R0
In Commercial Distribution

  • 08714729939603 ()


  • Cardiovascular ultrasound imaging system

FFR Link - 08714729939597

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100H0
In Commercial Distribution

  • 08714729939597 ()


  • Cardiovascular ultrasound imaging system

RHYTHMIA HDx™ - 08714729938736

Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20010
In Commercial Distribution

  • 08714729938736 ()
M004RH20010

  • Electromagnetic surgical navigation device tracking system

RHYTHMIA HDx™ - 08714729938712

Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH10200
In Commercial Distribution

  • 08714729938712 ()


  • Transducer signal amplifier

RHYTHMIA HDx™ - 08714729938682

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2EN0
In Commercial Distribution

  • 08714729938682 ()


  • Cardiac mapping system

LABSYSTEM™ PRO - 08714729935926

PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020350
In Commercial Distribution

  • 08714729935926 ()


  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935919

Adapter Kit PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020320
In Commercial Distribution

  • 08714729935919 ()


  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935902

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034R0
Not in Commercial Distribution

  • 08714729935902 ()
M0042002034R0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935896

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034H0
Not in Commercial Distribution

  • 08714729935896 ()
M0042002034H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935889

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034D0
Not in Commercial Distribution

  • 08714729935889 ()
M0042002034D0

  • General-purpose multi-parameter bedside monitor
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