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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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RHYTHMIA HDx™ - 08714729948384

Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15010
In Commercial Distribution

  • 08714729948384 ()
M004RH15010

  • Foot-switch, electrical

iLab™ Polaris Multi-Modality Guidance System - 08714729946137

Integrated System
BOSTON SCIENTIFIC CORPORATION
H74939322120I0
In Commercial Distribution

  • 08714729946137 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946120

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CR0
In Commercial Distribution

  • 08714729946120 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946113

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CD0
In Commercial Distribution

  • 08714729946113 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946106

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120C0
In Commercial Distribution

  • 08714729946106 ()


  • Cardiovascular ultrasound imaging system

IBP Cable Kit - 08714729940425

Connecting Cable, Cable Adapter
BOSTON SCIENTIFIC CORPORATION
H7495553710
In Commercial Distribution

  • 08714729940425 ()


  • Cardiovascular ultrasound imaging system

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

LABSYSTEM™ PRO - 08714729935872

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420020340
Not in Commercial Distribution

  • 08714729935872 ()
M00420020340

  • General-purpose multi-parameter bedside monitor

Rhythmia™ Mapping System - 08714729907060

IntellaNav™ CB - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62500
In Commercial Distribution

  • 08714729907060 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729905899

ECG Out Box and Cable Kit 1 US
BOSTON SCIENTIFIC CORPORATION
M004RB5000US0
In Commercial Distribution

  • 08714729905899 ()


  • Cardiac mapping system

iLab Ultrasound Imaging System - 08714729902911

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240C271R0
In Commercial Distribution

  • 08714729902911 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729902904

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240C2710
In Commercial Distribution

  • 08714729902904 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729902867

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220C271R0
In Commercial Distribution

  • 08714729902867 ()


  • Cardiovascular ultrasound imaging system

GE Hemodynamic Cable Kit - 08714729897217

Connecting Cable
BOSTON SCIENTIFIC CORPORATION
H7495551310
In Commercial Distribution

  • 08714729897217 ()


  • Cardiovascular ultrasound imaging system

NA - 08714729895862

Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I5033EUR0
In Commercial Distribution

  • 08714729895862 ()


  • Cardiovascular ultrasound imaging system

FFR Link - 08714729890010

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H7495551000
In Commercial Distribution

  • 08714729890010 ()


  • Cardiovascular ultrasound imaging system

MDU5 PLUS - 08714729887560

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUSRR0
In Commercial Distribution

  • 08714729887560 ()


  • Cardiovascular ultrasound imaging system

LABSYSTEM™ PRO - 08714729886013

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029R0
Not in Commercial Distribution

  • 08714729886013 ()
M0042002029R0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729886006

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029H0
Not in Commercial Distribution

  • 08714729886006 ()
M0042002029H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729885993

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029D0
Not in Commercial Distribution

  • 08714729885993 ()
M0042002029D0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729883999

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420020290
Not in Commercial Distribution

  • 08714729883999 ()
M00420020290

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729883920

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042001994R0
In Commercial Distribution

  • 08714729883920 ()
M0042001994R0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729883913

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042001994H0
In Commercial Distribution

  • 08714729883913 ()
M0042001994H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729883906

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042001994D0
In Commercial Distribution

  • 08714729883906 ()
M0042001994D0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729883678

VGA Image Capture Option Hardware Kit For LABSYSTEM™ PRO EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420019530
In Commercial Distribution

  • 08714729883678 ()


  • Multiple physiological signal amplifier

LABSYSTEM™ PRO - 08714729883654

VGA Image Capture Option Board For LABSYSTEM™ PRO EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420019520
In Commercial Distribution

  • 08714729883654 ()


  • Multiple physiological signal amplifier

Rhythmia™ Mapping System - 08714729880318

Magnetic Tracking System Kit
BOSTON SCIENTIFIC CORPORATION
M004RBLMR100
In Commercial Distribution

  • 08714729880318 ()


  • Electromagnetic surgical navigation device tracking system

Rhythmia™ Mapping System - 08714729863199

Rhythmia Global Install Bundle
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL10
In Commercial Distribution

  • 08714729863199 ()


  • Cardiac mapping system

OPAL HDx™ - 00191506055370

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system

OPAL HDx™ - 00191506055325

Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system

OPAL HDx™ - 00191506055301

Mapping System Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004OPAL40100
In Commercial Distribution

  • 00191506055301 ()
M004OPAL40100

  • Cardiac mapping system

Rhythmia HDx™ Mapping System - 00191506000813

Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH20
In Commercial Distribution

  • 00191506000813 ()
M004RAPATCH20

  • Cardiac mapping system reference patch

Nuubo System - 08437011759092

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

SYNESCOPE - 08031527015040

No Description
MICROPORT CRM SRL
UPGRADE TO SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527015040 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNESCOPE - 08031527015033

No Description
MICROPORT CRM SRL
NETWORK LICENCE V3,10 USB
In Commercial Distribution

  • 08031527015033 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014944

No Description
MICROPORT CRM SRL
V3.10 UPG TO USB COM
In Commercial Distribution

  • 08031527014944 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014913

No Description
MICROPORT CRM SRL
V3.10 Network Lic.USB
In Commercial Distribution

  • 08031527014913 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014296

No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNESCOPE - 08031527014289

No Description
MICROPORT CRM SRL
SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527014289 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNECOM - 08031527013435

No Description
MICROPORT CRM SRL
V3.10
In Commercial Distribution

  • 08031527013435 ()


  • Electrocardiographic long-term ambulatory recording analyser

Premier Heart MCG - B320CF190

Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel
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