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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DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer
External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-003
In Commercial Distribution

  • 10855728005892 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-001
In Commercial Distribution

  • 10855728005458 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

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

  • 00840682141161 ()


  • Breast ultrasound imaging system
No Description
BIOTRONIK SE & Co. KG
470662
In Commercial Distribution

  • 04035479177768 ()
470662

  • Cardiac pulse generator reader, home-use
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