15 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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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. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
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. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
Anti-Fyb Coombs-reactive, polyclonal, human
Device
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·On the market
Anti-Fyb Coombs-reactive, polyclonal, human
Device
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·On the market
Anti-Fyb for card method, Coombs-reactive, polyclonal, human
Device
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·On the market
Bottom Mattress HFB
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Funke Medical GmbH·1 device
Anti-Fyb Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
Anti-Fyb Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH·July 2, 2014
Anti-Fyb for card method, Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
HaB GmbH
Importer
🇩🇪 Germany
HaB GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·2 Devices
medac GmbH
Importer
🇩🇪 Germany·7 Manufacturers
ANTEX MEDI SOLUTION
Authorized representative
🇩🇪 Germany·26 Manufacturers·11971 Devices
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices