13 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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DHMF-2000/RALG
Device
EU MDR
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Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
DHMF-2000/LG
Device
EU MDR
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Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
DHMF-1000/RALG
Device
EU MDR
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Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
DHMF-1000/LG
Device
EU MDR
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Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
STERILIZATION TRAY ACCESSORIES ENT/CMF
Device
EU MDR
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Eu Md Class 1
·Brainlab AG·On the market
Universal CMF System
FDA 510(k)
FDA Class 2
·Dental
Stryker CMF MEDPOR Priority Customized Implant Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
FDA 510(k)
FDA Class 2
·Radiology
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.
FDA Enforcement
Class II
·Terminated·Brainlab AG·October 30, 2019
HMT Medizintechnik
Importer
🇩🇪 Germany
Fia Biomed GmbH
Importer
🇩🇪 Germany·1 Manufacturer
HMT Medizintechnik GmbH
System producer
🇩🇪 Germany
LOGON OMF Bioactive Systems GmbH
System producer
🇩🇪 Germany