10 results
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15ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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JFA Flock Applikationen GmbH
Manufacturer
🇩🇪 Germany
Anti-Jka Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
Anti-Jka monoclonal, human IgM clone: MS-15
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
Anti-Jka for card method, Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
Anti-Jka for card method, monoclonal, human IgM clone: MS-15
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
FDA Enforcement
Class II
·Terminated·Brainlab AG·September 4, 2013
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·May 1, 2019
TÜV Rheinland LGA Products GmbH
Notified body
🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs
Share info GmbH
Authorized representative
🇩🇪 Germany·154 Manufacturers·1206 Devices
Sungo Cert GmbH
Authorized representative
🇩🇪 Germany·173 Manufacturers·3269 Devices