63 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
FDA 510(k)
FDA Class 2
·Neurology
myQA iON; Article Number: MQ10-000;
FDA Enforcement
Class II
·Ongoing·IBA Dosimetry GmbH·May 7, 2025
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Meditec AG·May 4, 2022
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·January 27, 2016
ALEGRO Alginate
Device
EU MDR
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Eu Md Class 1
·Alegro Medical GmbH·On the market
4-motion® knee inlay
Device
EU MDD
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Eu Md Class 3
·ARTIQO GmbH·On the market·1 country
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
FDA 510(k)
FDA Class 1
·Radiology
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 11, 2017
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
FDA 510(k)
FDA Class 2
·Orthopedic
Gehwagen
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·2 devices
Gehwagen
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·3 devices
Lauflernhilfen
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·2 devices
Lauflernhilfen
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·2 devices
Rollatoren
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·1 device
Rollatoren
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·6 devices
Gehgestelle
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·6 devices
Griffe und Handläufe
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·1 device
Duschhocker
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·3 devices
Duschhocker
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·1 device
Multifunktions-Pflegerollstühle
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·REBOTEC Rehabilitationsmittel GmbH·5 devices