15 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VMA Motion Normalizer
FDA UDI
ORTHO KINEMATICS, INC.·00868579000247·VMA Motion Normalizer (Console, Table, and Upri...
VMA
FDA UDI
ORTHO KINEMATICS, INC.·00868579000209·
VMA DataLink Software
FDA UDI
ORTHO KINEMATICS, INC.·00868579000216·
Profile-ESP Radiographic marker
FDA UDI
ORTHO KINEMATICS, INC.·00868579000278·The Profile-ESP Radiographic Marker is an acces...
Profile-ESP Bolster
FDA UDI
ORTHO KINEMATICS, INC.·00868579000261·The Profile-ESP Bolster device is an optional p...
VMA Image Acquisition Software
FDA UDI
ORTHO KINEMATICS, INC.·00868579000230·VMA Image Acquisition Software (SW1) installed ...
VMA DataLink Software
FDA UDI
ORTHO KINEMATICS, INC.·00868579000223·VMA DataLink Software (SW4) available to custom...
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·August 12, 2016
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·January 11, 2017
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·May 23, 2018
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·March 2, 2017
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018