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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EGM Out to Signal Station Cable (IBI™)
BOSTON SCIENTIFIC CORPORATION
M004RA61020
In Commercial Distribution

  • 08714729971306 ()
M004RA61020

  • Electrical-only medical device connection cable, reusable
EGM Out to Signal Station Cable (Stockert™)
BOSTON SCIENTIFIC CORPORATION
M004RA60020
In Commercial Distribution

  • 08714729971290 ()
M004RA60020

  • Electrical-only medical device connection cable, reusable
Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020R0
In Commercial Distribution

  • 08714729965879 ()


  • Transducer signal amplifier
Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020H0
In Commercial Distribution

  • 08714729965862 ()


  • Transducer signal amplifier
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBEVAL2END0
In Commercial Distribution

  • 08714729960096 ()


  • Cardiac mapping system
Signal Station Kit
BOSTON SCIENTIFIC CORPORATION
M004RH1000R0
In Commercial Distribution

  • 08714729952862 ()


  • Transducer signal amplifier
Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40100
In Commercial Distribution

  • 08714729948407 ()
M004RH40100

  • Cardiac mapping system
Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15010
In Commercial Distribution

  • 08714729948384 ()
M004RH15010

  • Foot-switch, electrical
Integrated System
BOSTON SCIENTIFIC CORPORATION
H74939322120I0
In Commercial Distribution

  • 08714729946137 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CR0
In Commercial Distribution

  • 08714729946120 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CD0
In Commercial Distribution

  • 08714729946113 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120C0
In Commercial Distribution

  • 08714729946106 ()


  • Cardiovascular ultrasound imaging system
Connecting Cable, Cable Adapter
BOSTON SCIENTIFIC CORPORATION
H7495553710
In Commercial Distribution

  • 08714729940425 ()


  • Cardiovascular ultrasound imaging system
FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100R0
In Commercial Distribution

  • 08714729939603 ()


  • Cardiovascular ultrasound imaging system
FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100H0
In Commercial Distribution

  • 08714729939597 ()


  • Cardiovascular ultrasound imaging system
Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20010
In Commercial Distribution

  • 08714729938736 ()
M004RH20010

  • Electromagnetic surgical navigation device tracking system
Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH10200
In Commercial Distribution

  • 08714729938712 ()


  • Transducer signal amplifier
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2EN0
In Commercial Distribution

  • 08714729938682 ()


  • Cardiac mapping system
PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020350
In Commercial Distribution

  • 08714729935926 ()


  • General-purpose multi-parameter bedside monitor
Adapter Kit PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020320
In Commercial Distribution

  • 08714729935919 ()


  • General-purpose multi-parameter bedside monitor
EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034R0
Not in Commercial Distribution

  • 08714729935902 ()
M0042002034R0

  • General-purpose multi-parameter bedside monitor
EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034H0
Not in Commercial Distribution

  • 08714729935896 ()
M0042002034H0

  • General-purpose multi-parameter bedside monitor
EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034D0
Not in Commercial Distribution

  • 08714729935889 ()
M0042002034D0

  • General-purpose multi-parameter bedside monitor
EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420020340
Not in Commercial Distribution

  • 08714729935872 ()
M00420020340

  • General-purpose multi-parameter bedside monitor
IntellaNav™ CB - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62500
In Commercial Distribution

  • 08714729907060 ()


  • Cardiac mapping system
ECG Out Box and Cable Kit 1 US
BOSTON SCIENTIFIC CORPORATION
M004RB5000US0
In Commercial Distribution

  • 08714729905899 ()


  • Cardiac mapping system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CART0
In Commercial Distribution

  • 08714729780205 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CART0
In Commercial Distribution

  • 08714729777694 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CARTR0
In Commercial Distribution

  • 08714729854029 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CARTR0
In Commercial Distribution

  • 08714729854012 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CARTR0
In Commercial Distribution

  • 08714729854005 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CARTD0
In Commercial Distribution

  • 08714729853992 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CARTD0
In Commercial Distribution

  • 08714729853985 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CARTD0
In Commercial Distribution

  • 08714729853978 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTBD0
In Commercial Distribution

  • 08714729853961 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTBD0
In Commercial Distribution

  • 08714729853954 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTB0
In Commercial Distribution

  • 08714729853923 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120C271R0
In Commercial Distribution

  • 08714729853916 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100CART0
In Commercial Distribution

  • 08714729761235 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INS0
In Commercial Distribution

  • 08714729765127 ()


  • Cardiovascular ultrasound imaging system
Holter prep kit with AA battery cleared with Vision 5LR recorder
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution

  • 10812345029939 ()
  • 20812345029936 ()
  • 30812345029933 ()


  • Electrocardiographic ambulatory recorder
Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system
Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.
SMART SOLUTIONS TECHNOLOGIES SL
1935
In Commercial Distribution

  • 08437011759092 ()
1935

  • Electrocardiographic long-term ambulatory recording analyser application software
PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
AE-0001-412
Not in Commercial Distribution

  • 08567500070008 ()
AE-0001-412

  • Cardiac electrophysiology analysis system
Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I50330
In Commercial Distribution

  • 08714729229513 ()


  • Cardiovascular ultrasound imaging system
Disposable Pullback Sled for Motordrive
BOSTON SCIENTIFIC CORPORATION
H749A70200
In Commercial Distribution

  • 08714729228684 ()


  • Cardiovascular ultrasound imaging system
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software
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