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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No Description
BIOTRONIK SE & Co. KG
470662
In Commercial Distribution

  • 04035479177768 ()
470662

  • Cardiac pulse generator reader, home-use
Ablation Connection Box (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA65010
In Commercial Distribution

  • 00191506020804 ()
M004RA65010

  • Cardiac mapping system
Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

  • Cardiac mapping system
Ablation Connection Box
BOSTON SCIENTIFIC CORPORATION
M004RA6301US0
In Commercial Distribution

  • 00191506034429 ()
M004RA6301US0

  • Cardiac mapping system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS 2.0
In Commercial Distribution

  • 00840682141161 ()


  • Breast ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

  • Breast ultrasound imaging system
Invenia ABUS Scan Station-US Global
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Scan Station
In Commercial Distribution

  • 00840682100021 ()


  • Breast ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS System
Not in Commercial Distribution

  • 00840682100014 ()
H5014PM

  • Breast ultrasound imaging system
single use accessory for ZEISS femtosecond lasers
Carl Zeiss Meditec AG
1016
In Commercial Distribution

  • 04049471100167 ()
  • 04049471110166 ()


  • Femtosecond ophthalmic solid-state laser system
single use accessory for ZEISS femtosecond lasers
Carl Zeiss Meditec AG
1015
In Commercial Distribution

  • 04049471100150 ()
  • 04049471110159 ()


  • Femtosecond ophthalmic solid-state laser system
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