137 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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LOGON OMF Bioactive Systems GmbH
Manufacturer
🇩🇪 Germany
STERILIZATION TRAY ACCESSORIES ENT/CMF
Device
EU MDR
·
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
KULZER GmbH
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Zrinski Solution GbR
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.
newbox medical GmbH
Manufacturer
🇩🇪 Germany·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Gründler GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY
Udo Heisig GmbH The Disposables Company
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH
GEOMED Medizin-Technik GmbH & Co. KG
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH
E. HAHNENKRATT GmbH
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH
Gebr. Brasseler GmbH & Co. KG
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH
terraplasma medical GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH
Fiagon GmbH
Manufacturer
🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY
Löwenstein Medical Technology GmbH + Co. KG
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH
Carl Martin GmbH
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH
Erkodent Erich Kopp GmbH
Manufacturer
🇩🇪 Germany·11 Basic UDI-DIs·43 Devices·TÜV Rheinland LGA Products GmbH
SICAT GmbH & Co. KG
Manufacturer
🇩🇪 Germany·5 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH