5 results
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14ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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MB Guided Surgery Tools Kit - IHX Implants
Device
EU MDR
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Eu Md Class 2a
·MEDIGMA BIOMEDICAL GMBH·On the market·32 countries
MB Guided Surgery Tools Kit - IHX Implants
Device
EU MDD
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Eu Md Class 2a
·MEDIGMA BIOMEDICAL GMBH·On the market·32 countries
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
FDA 510(k)
FDA Class 2
·Cardiovascular
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
FDA 510(k)
FDA Class 2
·Cardiovascular
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025