15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Universitätsklinikum Bonn AöR
Manufacturer
🇩🇪 Germany
Ador Edelmetalle GmbH
Manufacturer
🇩🇪 Germany
C4 / 1-or 4 chamber with central valve
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Wolff Kunststoffe GmbH·26 devices
Ador Edelmetalle GmbH
Importer
🇩🇪 Germany
Medutek Handelsgesellschaft für Medizintechnik mbH & Co. KG
Importer
🇩🇪 Germany·2 Manufacturers
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 20, 2014
for you eHealth GmbH
System producer
🇩🇪 Germany
SPIGGLE &THEIS Medizintechnik GmbH
Importer
🇩🇪 Germany·19 Manufacturers
DE/CA59, Regierung der Oberpfalz - Gewerbeaufsichtsamt - Kompetenzzentrum Marktüberwachung
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA98 - Bundeswehr Commissioner for Medicinal Product Supervision
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
JaviTech e.K.
Authorized representative
🇩🇪 Germany·111 Manufacturers·1816 Devices
DE/CA196, Bundesamt fur lnfrastruktur, Umweltschutz und Dienstleistungen der Bundeswehr GS ÖrABw
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA197, Kommando Sanitätsdienst der Bundeswehr Sachgebiet V 1.4 Arzneimittel- und Medizinproduktesicherheit
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA99 - Federal Institute for Drugs and Medical Devices, Medical Devices Division
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA162, Sächsisches Staatsministerium fur Soziales und Gesellschaftlichen Zusammenhalt Saxon State Ministry For Social Affairs and Cohesion
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices