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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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Endoflip - 10884521826809

300 Pump System With Pre-Use Tube
Covidien LP
EF-301
In Commercial Distribution

  • 10884521826809 ()


  • Manometric gastrointestinal motility analysis system

Nuubo System - 08437011759078

NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.
SMART SOLUTIONS TECHNOLOGIES SL
2140
In Commercial Distribution

  • 08437011759078 ()
2140

  • Electrocardiographic ambulatory recorder

Villa Sistemi Medicali - 08057737122361

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343-TS
In Commercial Distribution

  • 08057737122361 ()


  • Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali - 08057737122262

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343 FL
In Commercial Distribution

  • 08057737122262 ()


  • Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali - 08057737122217

No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343
In Commercial Distribution

  • 08057737122217 ()


  • Diagnostic x-ray digital imaging system workstation

Smart ECG - 08031527017334

MicroPort CRM Smart ECG
MICROPORT CRM SRL
K379
In Commercial Distribution

  • 08031527017334 ()
K379

  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527015149

No Description
MICROPORT CRM SRL
Pouch
In Commercial Distribution

  • 08031527015149 ()


  • Electrocardiographic ambulatory recorder

CUSTODIA - 08031527015132

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527015132 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014890

No Description
MICROPORT CRM SRL
PLUS
In Commercial Distribution

  • 08031527014890 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW+ SD MEMORY CARD - 08031527014883

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527014883 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014876

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527014876 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW & SPIDERFLASH-T MEMORY CARD - 08031527013428

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527013428 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW SD MEMORY CARD - 08031527013411

No Description
MICROPORT CRM SRL
SD card
In Commercial Distribution

  • 08031527013411 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527013398

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527013398 ()


  • Electrocardiographic ambulatory recorder

7LS - 00031262096265

ReNew Light Therapy
FKA DISTRIBUTING CO., LLC
FA7-1450J
In Commercial Distribution

  • 00031262096265 ()
FA7-1450J

  • Red/blue light phototherapy unit

M12 System - 00815187020754

SD Card (GI Label)
GLOBAL INSTRUMENTATION, LLC
000-400-0129
In Commercial Distribution

  • 00815187020754 ()
000-400-0129

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020600

M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0195
In Commercial Distribution

  • 00815187020600 ()
009-400-0195

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020594

M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5 3-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0194
In Commercial Distribution

  • 00815187020594 ()
009-400-0194

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020587

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0193
In Commercial Distribution

  • 00815187020587 ()
009-400-0193

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020570

M5 Neck Lanyard
GLOBAL INSTRUMENTATION, LLC
009-400-0205
In Commercial Distribution

  • 00815187020570 ()
009-400-0205

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020563

M5 Recorder, USB Cable, USB Wall Charger, System Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0192
In Commercial Distribution

  • 00815187020563 ()
009-400-0192

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020556

M5 Recorder
GLOBAL INSTRUMENTATION, LLC
M5
In Commercial Distribution

  • 00815187020556 ()
009-400-0180

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020549

M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0178
In Commercial Distribution

  • 00815187020549 ()
009-400-0178

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020471

M5 4-Lead Patient Cable - RL Lead AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0171
In Commercial Distribution

  • 00815187020471 ()
009-400-0171

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020457

M5 3-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0169
In Commercial Distribution

  • 00815187020457 ()
009-400-0169

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020440

M5 2-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0168
In Commercial Distribution

  • 00815187020440 ()
009-400-0168

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020433

M5 Patch Electrode, 2-Lead
GLOBAL INSTRUMENTATION, LLC
009-400-0167
In Commercial Distribution

  • 00815187020433 ()
009-400-0167

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020112

M5 Patient Cable Cradle
GLOBAL INSTRUMENTATION, LLC
009-400-0206
In Commercial Distribution

  • 00815187020112 ()
009-400-0206

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB12511

1AXe Wearable Biosensor
Lifesignals, Inc.
UB1251
In Commercial Distribution

  • B353UB12512 ()
  • B353UB12511 ()
  • B353UB12513 ()


  • Electrocardiographic ambulatory recorder

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

SurgicalPreview - B642SURGICALPREVIEW2400

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.4.0
In Commercial Distribution

SURGICALPREVIEW240

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2300

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.3.0
In Commercial Distribution

SURGICALPREVIEW230

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2200

Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.2.0
In Commercial Distribution

SURGICALPREVIEW220

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW2100 ()
SURGICALPREVIEW210

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW1200

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.2.0
In Commercial Distribution

  • B642SURGICALPREVIEW1200 ()
SURGICALPREVIEW120

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW1100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW1100 ()
SURGICALPREVIEW110

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.0
In Commercial Distribution

  • B642SURGICALPREVIEW100 ()
SURGICALPREVIEW10

  • Vascular modelling software

Mediblu - B632MDB01024

No Description
MEDIBLU MEDICAL LLC
HP50P
In Commercial Distribution

  • B632MDB01024 ()
MDB01024

  • Arrythmia-detection blood pressure ambulatory recorder

Mediblu - B632MDB01023

No Description
MEDIBLU MEDICAL LLC
HA3P
In Commercial Distribution

  • B632MDB01023 ()
MDB01023

  • Electrocardiographic ambulatory recorder

SurgicalPreview - B642SURGICALPREVIEW3300

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.
ENDOVANTAGE LLC
3.3.0
In Commercial Distribution

SURGICALPREVEW330

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW3200

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.
ENDOVANTAGE LLC
3.2.0
In Commercial Distribution

SURGICALPREVIEW320

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW3100

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.
ENDOVANTAGE LLC
3.1.0
In Commercial Distribution

SURGICALPREVIEW310

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW3000

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.
ENDOVANTAGE LLC
3.0.0
In Commercial Distribution

SURGICALPREVIEW300

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2600

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.
ENDOVANTAGE LLC
2.6.0
In Commercial Distribution

SURGICALPREVIEW260

  • Vascular modelling software
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