398 results
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30ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 16, 2022
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 17, 2021
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Brainlab AG·June 16, 2021
Albomed GmbH
Manufacturer
🇩🇪 Germany·11 Basic UDI-DIs·11 Devices·HTCert (Health Technology Certification Ltd)
VITA YZ® SOLUTIONS
Device
EU MDR
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Eu Md Class 2a
·VITA Zahnfabrik·On the market·1 country
VINCENTemg-monitor 2Kanal-koaxial
Device
EU MDR
·
Eu Md Class 1
·Vincent Systems GmbH·On the market
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
WHEELCHAIRS ACCESSORIES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·On the market·8 countries
Haltesysteme für Seitenpelotten
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Rolko Kohlgrüber GmbH·12 devices
530381 MR2
Certificate
MDD Annex II (excluding section 4)·Sanavita Pharmaceuticals GmbH·DQS Medizinprodukte GmbH·1 Basic UDI-DI