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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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AHVTE - 06972868590105

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MDY-001
In Commercial Distribution

  • 06972868590105 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590099

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY11
In Commercial Distribution

  • 06972868590099 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590082

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY10
In Commercial Distribution

  • 06972868590082 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590075

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY09
In Commercial Distribution

  • 06972868590075 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590068

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY08
In Commercial Distribution

  • 06972868590068 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590051

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY07
In Commercial Distribution

  • 06972868590051 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590044

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY06
In Commercial Distribution

  • 06972868590044 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590037

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY03
In Commercial Distribution

  • 06972868590037 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590020

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY02
In Commercial Distribution

  • 06972868590020 ()


  • Tooth-bleaching acceleration unit

AHVTE - 06972868590013

Tools & Accessories
FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTD
MYY01
In Commercial Distribution

  • 06972868590013 ()


  • Tooth-bleaching acceleration unit

OrthoGrid Hip Trauma - 00860003424827

OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-502
In Commercial Distribution

  • 00860003424827 ()


  • Orthopaedic fluoroscopic grid software

HeartMate 3™ - 05415067038418

Surgical Hand Tools
Thoratec Corporation
10002222US
In Commercial Distribution

10002222US

  • Cardiothoracic surgical procedure kit, non-medicated, reusable

Variobase C - 07630031749024

Planning & Design Tools
Institut Straumann AG
ScanPost S RB/WB L, TAN
In Commercial Distribution

  • 07630031749024 ()
065.0038

  • Dental implant suprastructure, temporary, preformed, single-use

DTI IMPLANT SISTEMLERI - 08680671491943

REMOVAL TOOLS STANDARD
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
SURGICAL KIT
In Commercial Distribution

  • 08680671491943 ()
DTIDRTOS

  • Surgical screwdriver, reusable

MIS - 07290109006437

Prosthetic tools kit
MIS Implants Technologies Ltd.
MK-0039
In Commercial Distribution

  • 07290109006437 ()
MK-0039

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

R4 ACERT - 00857926006001

No Description
HYLAND SOFTWARE, INC.
4.20.300
In Commercial Distribution

  • 00857926006001 ()


  • Radiological PACS software

MIMviewer - 00865936000285

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.8
Not in Commercial Distribution

  • 00865936000285 ()


  • Radiological PACS software

MIM - 00865936000278

A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging.
MIM SOFTWARE INC.
6.8
Not in Commercial Distribution

  • 00865936000278 ()


  • Radiological PACS software

MIM - 00865936000254

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
6.5
Not in Commercial Distribution

  • 00865936000254 ()


  • Radiological PACS software

MIMviewer - 00865936000247

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.7
Not in Commercial Distribution

  • 00865936000247 ()


  • Radiological PACS software

MIM - 00865936000230

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
6.7
Not in Commercial Distribution

  • 00865936000230 ()


  • Radiological PACS software

MIMviewer - 00865936000223

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.6
Not in Commercial Distribution

  • 00865936000223 ()


  • Radiological PACS software

Mobile MIM - 00865936000216

A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans.
MIM SOFTWARE INC.
4.0
Not in Commercial Distribution

  • 00865936000216 ()


  • Radiological PACS software

MIM - 00865936000209

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
6.6
Not in Commercial Distribution

  • 00865936000209 ()


  • Radiological PACS software

Mobile MIM - 00860148000832

A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans.
MIM SOFTWARE INC.
4.1
Not in Commercial Distribution

  • 00860148000832 ()


  • Radiological PACS software

MIM - 00860148000818

A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging.
MIM SOFTWARE INC.
6.9
Not in Commercial Distribution

  • 00860148000818 ()


  • Radiological PACS software

Mobile MIM - 00860148000894

A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans.
MIM SOFTWARE INC.
4.2
In Commercial Distribution

  • 00860148000894 ()


  • Radiological PACS software

MIMviewer - 00860148000870

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
4.0
Not in Commercial Distribution

  • 00860148000870 ()


  • Radiological PACS software

MIM - 00860148000863

A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging.
MIM SOFTWARE INC.
7.0
Not in Commercial Distribution

  • 00860148000863 ()


  • Radiological PACS software

MIMviewer - 00860148000825

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.9
Not in Commercial Distribution

  • 00860148000825 ()


  • Radiological PACS software

ContourProtégéAI - 00850009343307

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.3
In Commercial Distribution

  • 00850009343307 ()


  • Radiological PACS software

ContourProtégéAI - 00850009343291

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.2
In Commercial Distribution

  • 00850009343291 ()


  • Radiological PACS software

MIM - 00850009343284

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.4
In Commercial Distribution

  • 00850009343284 ()


  • Radiological PACS software

MIM - 00850009343277

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.3
In Commercial Distribution

  • 00850009343277 ()


  • Radiological PACS software

ContourProtégéAI - CT SurePlan MRT - 00850009343239

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343239 ()


  • Radiological PACS software

ContourProtégéAI - CT Lung and Liver - 00850009343215

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
2.0
In Commercial Distribution

  • 00850009343215 ()


  • Radiological PACS software

MIM - 00850009343192

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.2
In Commercial Distribution

  • 00850009343192 ()


  • Radiological PACS software

ContourProtégéAI - CT Abdomen - 00850009343178

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
2.0
In Commercial Distribution

  • 00850009343178 ()


  • Radiological PACS software

MIMcloud - 00850009343130

MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.13
In Commercial Distribution

  • 00850009343130 ()


  • Radiological PACS software

ContourProtégéAI - MR Prostate - 00850009343093

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343093 ()


  • Radiological PACS software

ContourProtégéAI - CT Prostate - 00850009343086

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343086 ()


  • Radiological PACS software

ContourProtégéAI - CT Liver - 00850009343079

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343079 ()


  • Radiological PACS software

ContourProtégéAI - CT Thorax - 00850009343062

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343062 ()


  • Radiological PACS software

ContourProtégéAI - CT Head and Neck - 00850009343055

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343055 ()


  • Radiological PACS software

MIMcloud - 00850009343031

MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.12
Not in Commercial Distribution

  • 00850009343031 ()


  • Radiological PACS software

MIM - 00850009343024

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.1
Not in Commercial Distribution

  • 00850009343024 ()


  • Radiological PACS software

RadCalc® - 00867520000206

RadCalc® #1 Trusted Dosimetric Verification Software. RadCalc Software. LifeLine Software, Inc.
LIFELINE SOFTWARE INC
RadCalc®
In Commercial Distribution

  • 00867520000206 ()


  • Radiation therapy software

Blood Product Questionnaire Module - 00860010651209

The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members
BUOY SOFTWARE, LLC
1
In Commercial Distribution

  • 00860010651209 ()


  • Blood bank information system application software

AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM - 00860010575307

The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software

EEGer4 - B258EEGER4

Neurofeedback Software
EEG SOFTWARE LLC
4
In Commercial Distribution

  • B258EEGER4 ()


  • Biofeedback system application software
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