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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™ - 08714729966326

Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729960096

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBEVAL2END0
In Commercial Distribution

  • 08714729960096 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948407

Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40100
In Commercial Distribution

  • 08714729948407 ()
M004RH40100

  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948377

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14510
In Commercial Distribution

  • 08714729948377 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948360

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14010
In Commercial Distribution

  • 08714729948360 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948322

Breakout Box
BOSTON SCIENTIFIC CORPORATION
M004RH11020
In Commercial Distribution

  • 08714729948322 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729938682

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2EN0
In Commercial Distribution

  • 08714729938682 ()


  • Cardiac mapping system

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

Quantib ND - 08719689791261

No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791261 ()


  • MRI system application software

Quantib Brain - 08719689791254

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software

Quantib ND - 08719689791216

No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software

Quantib ND - 08719689791179

No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software

Quantib ND - 08719689791148

No Description
Quantib B.V.
1.8
In Commercial Distribution

  • 08719689791148 ()


  • MRI system application software

Quantib ND - 08719689791094

No Description
Quantib B.V.
1.7
In Commercial Distribution

  • 08719689791094 ()


  • MRI system application software

Quantib Brain - 08719689791070

No Description
Quantib B.V.
1.4
In Commercial Distribution

  • 08719689791070 ()


  • MRI system application software

Quantib ND - 08719689791032

No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software

Quantib ND - 08719689791001

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791001 ()


  • MRI system application software

Cardiac Function Laboratory - 08717953256645

Inca PV loop system for the measurement of cardiac function and performance.
CD Leycom
CFL-M Inca
In Commercial Distribution

  • 08717953256645 ()
CDL001

  • Cardiac mapping system

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

Osstem - 08800000995014

The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Osstem Implant Co., Ltd._Gasan Branch
EXARO
In Commercial Distribution

  • 08800000995014 ()


  • Portable basic diagnostic x-ray system, digital

MP21 MR Coil Kit - 04056869049625

Contains Medical Device Mat. 8635612 (GTIN:04056869038858)
Siemens Shenzhen Magnetic Resonance Ltd.
10019213
In Commercial Distribution

  • 04056869049625 ()


  • Full-body MRI system, permanent magnet

Extremity small coil kit - 04056869049618

Contains Medical Device Mat. 8635596 (GTIN:04056869038834)
Siemens Shenzhen Magnetic Resonance Ltd.
10019208
In Commercial Distribution

  • 04056869049618 ()


  • Full-body MRI system, permanent magnet

Extremity L MR Coil Kit - 04056869049601

Contains Medical Device Mat. 8635588 (GTIN:04056869038827)
Siemens Shenzhen Magnetic Resonance Ltd.
10019205
In Commercial Distribution

  • 04056869049601 ()


  • Full-body MRI system, permanent magnet

Extremity XL MR Coil Kit - 04056869049595

Contains Medical Device Mat. 8635570 (GTIN:04056869038810)
Siemens Shenzhen Magnetic Resonance Ltd.
10019204
In Commercial Distribution

  • 04056869049595 ()


  • Full-body MRI system, permanent magnet

MP16 MR Coil Kit - 04056869049588

Contains Medical Device Mat. 8635604 (GTIN:04056869038841)
Siemens Shenzhen Magnetic Resonance Ltd.
10019203
In Commercial Distribution

  • 04056869049588 ()


  • Full-body MRI system, permanent magnet

Body Spine Array XXL MR Coil Kit - 04056869049571

Contains Medical Device Mat. 8635505 (GTIN:04056869038766)
Siemens Shenzhen Magnetic Resonance Ltd.
10019202
In Commercial Distribution

  • 04056869049571 ()


  • Full-body MRI system, permanent magnet

syngo.mMR General - 04056869043227

SW Version VB20
Siemens Healthcare GmbH
11291464
In Commercial Distribution

  • 04056869043227 ()


  • MRI system application software

syngo.MR BreVis - 04056869043210

SW Version VB20
Siemens Healthcare GmbH
11291463
In Commercial Distribution

  • 04056869043210 ()


  • MRI system application software

syngo.MR Vascular - 04056869043203

SW Version VB20
Siemens Healthcare GmbH
11291462
In Commercial Distribution

  • 04056869043203 ()


  • MRI system application software

syngo.MR Spectroscopy - 04056869043197

SW Version VB20
Siemens Healthcare GmbH
11291461
In Commercial Distribution

  • 04056869043197 ()


  • MRI system application software

syngo.MR Oncology - 04056869043180

SW Version VB20
Siemens Healthcare GmbH
11291460
In Commercial Distribution

  • 04056869043180 ()


  • MRI system application software

syngo.MR Neurology - 04056869043173

SW Version VB20
Siemens Healthcare GmbH
11291459
In Commercial Distribution

  • 04056869043173 ()


  • MRI system application software

syngo.MR Cardiology - 04056869043166

SW Version VB20
Siemens Healthcare GmbH
11291458
In Commercial Distribution

  • 04056869043166 ()


  • MRI system application software

syngo.MR General - 04056869043159

SW Version VB20
Siemens Healthcare GmbH
11291457
In Commercial Distribution

  • 04056869043159 ()


  • MRI system application software

Body Spine Array L MR Coil Kit - 04056869042299

Contains Medical Device Mat. 8635521 (GTIN:04056869039169)
Siemens Shenzhen Magnetic Resonance Ltd.
10019289
In Commercial Distribution

  • 04056869042299 ()


  • Full-body MRI system, permanent magnet

Body spine array L C035 - 04056869039169

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635521
In Commercial Distribution

  • 04056869039169 ()


  • Full-body MRI system, permanent magnet

Wrist Array Coil C035(4 CH) - 04056869038902

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10045324
In Commercial Distribution

  • 04056869038902 ()


  • Full-body MRI system, permanent magnet

Breast coil c035 - 04056869038896

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10019366
In Commercial Distribution

  • 04056869038896 ()


  • Full-body MRI system, permanent magnet

Body Spine Array Coil XL - 04056869038889

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635513
In Commercial Distribution

  • 04056869038889 ()


  • Full-body MRI system, permanent magnet

Neck Coil M C035 - 04056869038872

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635679
In Commercial Distribution

  • 04056869038872 ()


  • Full-body MRI system, permanent magnet

Shoulder Array Coil - 04056869038865

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635620
In Commercial Distribution

  • 04056869038865 ()


  • Full-body MRI system, permanent magnet

Multipurpose Coil 21 C035 - 04056869038858

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635612
In Commercial Distribution

  • 04056869038858 ()


  • Full-body MRI system, permanent magnet

Multipurpose Coil 16S C035 - 04056869038841

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635604
In Commercial Distribution

  • 04056869038841 ()


  • Full-body MRI system, permanent magnet

Extremity Array Coil S - 04056869038834

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635596
In Commercial Distribution

  • 04056869038834 ()


  • Full-body MRI system, permanent magnet

Extremity Array Coil L - 04056869038827

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635588
In Commercial Distribution

  • 04056869038827 ()


  • Full-body MRI system, permanent magnet

Extremity XL C035 - 04056869038810

MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
08635570
In Commercial Distribution

  • 04056869038810 ()


  • Full-body MRI system, permanent magnet
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