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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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The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series
Varex Imaging Nederland B.V.
13034-10
In Commercial Distribution

  • 08718755000931 ()


  • Multichannel radiation survey meter
Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XL C015
In Commercial Distribution

  • 08053470960017 ()


  • Diagnostic x-ray digital imaging system workstation
Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XS C015
In Commercial Distribution

  • 08053470960000 ()


  • Diagnostic x-ray digital imaging system workstation
Light therapy acne mask
Kenvue Brands LLC
00070501302743
Not in Commercial Distribution

  • 00070501302743 ()


  • Red/blue light phototherapy unit
Light therapy acne mask
Kenvue Brands LLC
00070501260395
Not in Commercial Distribution

  • 00070501260395 ()


  • Red/blue light phototherapy unit
Light therapy acne mask
Kenvue Brands LLC
00070501260364
Not in Commercial Distribution

  • 00070501260364 ()


  • Red/blue light phototherapy unit
Light Therapy Acne Spot Treatment
Kenvue Brands LLC
00070501101315
Not in Commercial Distribution

  • 00070501101315 ()


  • Red/blue light phototherapy unit
Light Therapy Acne Mask Activator
Kenvue Brands LLC
00070501101261
Not in Commercial Distribution

  • 00070501101261 ()


  • Red/blue light phototherapy unit
Light Therapy Acne Mask
Kenvue Brands LLC
00070501101247
Not in Commercial Distribution

  • 00070501101247 ()


  • Red/blue light phototherapy unit
No Description
Ablenet, Inc.
10000033
In Commercial Distribution

  • 00186648000609 ()
10000033

  • Assistive human interface device proximal control, hand-operated
Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
17883-10
In Commercial Distribution

  • 08718755000986 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14181-10
In Commercial Distribution

  • 08718755000962 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14315-10
In Commercial Distribution

  • 08718755000948 ()


  • Multichannel radiation survey meter
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
12860-10
In Commercial Distribution

  • 08718755000924 ()


  • Multichannel radiation survey meter
SOLAR Compact
Laborie Medical Technologies Corp.
G4-1
In Commercial Distribution

  • 08720648846052 ()


  • Manometric gastrointestinal motility analysis system
Solar GI air-charged 4P, Compact Pole system, 115V
Medical Measurement Systems B.V.
G3-7 Air
In Commercial Distribution

  • 08720648846007 ()


  • Manometric gastrointestinal motility analysis system
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Light Tree Ventures Europe B.V.
P19-0007
In Commercial Distribution

  • 08720299044227 ()


  • Red/blue light phototherapy unit
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
Solar GI Trolley
Medical Measurement Systems B.V.
GI trolley white
In Commercial Distribution

  • 08717775957003 ()
GI trolley white

  • Manometric gastrointestinal motility analysis system
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343-TS
In Commercial Distribution

  • 08057737122361 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343 FL
In Commercial Distribution

  • 08057737122262 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343
In Commercial Distribution

  • 08057737122217 ()


  • Diagnostic x-ray digital imaging system workstation
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® 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® 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® 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
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
2.5.0
In Commercial Distribution

SURGICALPREVIEW250

  • Vascular modelling software
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
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