9 results · 41ms · Sources: EU EUDAMED, US FDA

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GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 2b ·VIDAL FRANCE·On the market·7 countries

GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 2b ·VIDAL FRANCE·On the market·7 countries

GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 2b ·VIDAL FRANCE·On the market·7 countries

VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Device
EU IVDR · Eu Ivd Class C ·SEQONE·On the market·12 countries

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDD · Eu Md Class 1 ·AbilyCare·On the market

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 1 ·Resilience MD·On the market·2 countries

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 2a ·Resilience MD·On the market·1 country

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 2a ·i-Virtual·On the market·13 countries

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

FDA Enforcement
Class II ·Ongoing·QUANTUM SURGICAL SAS·June 18, 2025