13 results
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44ms
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Sources: EU EUDAMED, US FDA
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
FDA Recall
Terminated
·Vision Rt Inc·Product code IYE·October 15, 2014
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
FDA Recall
Terminated
·Vision Rt Inc·Product code IYE·November 11, 2014
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·January 14, 2015
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·December 3, 2014
ACRYSOF IOL LENSES
FDA Adverse Event
Injury
·ALCON·Product code HQL·May 1, 2018
Tema Sinergie S.p.A.
Importer
🇮🇹 Italy·7 Manufacturers
MedEnvoy Global BV
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🇳🇱 Netherlands·234 Manufacturers
MYM SOPORTE TECNICO Y DE CALIDAD, S.L.
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🇪🇸 Spain·20 Manufacturers·36 Devices
Emergo Europe B.V.
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🇳🇱 Netherlands·900 Manufacturers·22100 Devices
mdi Europa GmbH
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🇩🇪 Germany·132 Manufacturers·4741 Devices
Obelis s.a.
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CMC Medical Devices & Drugs SL
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Sungo Cert GmbH
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🇩🇪 Germany·173 Manufacturers·3269 Devices